Drug development and nda

.
HISTORY AND VARIOUS PHASES
OF DRUG DEVELOPMENT AND
DRUG APPROVAL PROCESS,
NDA
03/22/15www.PharmInfopedia.com

History of drug development & drug approval process
Various phases of drug development & drug approval
process
NDA
References

Year Milestone
1820
Eleven physicians met in Washington,
D.C., to establish the U.S. Pharmacopeia,
the first compendium of standard drugs for
the U.S.
1848
Drug Importation Act passed by Congress
requires U.S. Customs Service inspection
to stop entry of adulterated drugs from
overseas. 03/22/15www.PharmInfopedia.com

1905
Samuel Hopkins Adams' ten-part exposé of
the patent medicine industry, "The Great
American Fraud," begins in Collier's.
The American Medical Association,
through its Council on Pharmacy and
Chemistry, initiates a voluntary program of
drug approval that would last until 1955.
To earn the right to advertise in AMA and
related journals, companies submitted
evidence, for review by the Council and
outside experts, to support their therapeutic
claims for drugs.

1906
The original Food and Drugs Act is passed
by Congress on June 30 and signed by
President Theodore Roosevelt. It prohibits
interstate commerce in misbranded and
adulterated foods and drugs. The Meat
Inspection Act is passed the same day.
Shocking disclosures of insanitary
conditions in meat-packing plants, the use
of poisonous preservatives and dyes in
foods, and cure-all claims for worthless
and dangerous patent medicines were the
major problems leading to the enactment
of these laws.

1912
Congress enacts the Sherley
Amendment to overcome the
ruling in U.S. v. Johnson. It
prohibits labeling medicines with
false therapeutic claims intended
to defraud the purchaser, a
standard difficult to prove.

1914
The Harrison Narcotic Act imposes
upper limits on the amount of opium,
opium-derived products, and cocaine
allowed in products available to the
public; requires prescriptions for
products exceeding the allowable
limit of narcotics; and mandates
increased record-keeping for
physicians and pharmacists that
dispense narcotics. A separate law
dealing with marihuana would be
enacted in 1937.

1933
FDA recommends a complete revision
of the obsolete 1906 Food and Drugs
Act. The first bill is introduced into
the Senate, launching a five-year
legislative battle. FDA assembles a
graphic display of shortcomings in
P'ceutical & other regulation under the
1906 Act, dubbed by one reporter as
the Chamber of Horrors, exhibited
nationwide to help draw support for a
new law.

1937
Elixir Sulfanilamide, containing the
poisonous solvent diethylene glycol,
kills 107 persons, many of whom are
children, dramatizing the need to
establish drug safety before
marketing and to enact the pending
food and drug law.

1938
The Federal Food, Drug, and Cosmetic
Act of 1938 is passed by Congress,
containing new provisions:
1. Requiring new drugs to be shown
safe before marketing -starting a new
system of drug regulation.
2. Eliminating the Sherley Amendment
requirement to prove intent to
defraud in drug misbranding cases.
3. Extending control to cosmetics and
therapeutic devices.

4. Providing that safe tolerances
should be set for unavoidable
poisonous substances.
5. Authorizing standards of identity,
quality, and fill-of-container for
foods.
6. Authorizing factory inspections.
7. Adding the remedy of court
injunctions to the previous
penalties of seizures and
prosecutions.

1938
Under the Wheeler-Lea Act, the Federal
Trade Commission is charged to oversee
advertising associated with products,
including pharmaceuticals, otherwise
regulated by FDA.
FDA promulgates the policy in August
that sulfanilamide and selected other
dangerous drugs must be administered
under the direction of a qualified expert,
thus launching the requirement for
prescription only (non-narcotic) drugs.

1941
Insulin Amendment requires FDA to
test & certify purity & potency of this
life-saving drug for diabetes.
Nearly 300 deaths and injuries result
from distribution of sulfathiazole tablets
tainted with the sedative, phenobarbital.
The incident prompts FDA to revise
manufacturing & quality controls
drastically, the beginning of what would
later be called good manufacturing
practices (GMPs).

1945
Penicillin Amendment
requires FDA testing and
certification of safety and
effectiveness of all penicillin
products. Later amendments
would extend this
requirement to all antibiotics.
In 1983 such control would
be found no longer needed
and abolished.

1948
Supreme Court rules in U. S. v. Sullivan
that FDA's jurisdiction extends to the
retail distribution, thereby permitting
FDA to interdict in pharmacies illegal
sales of drugs--the most problematical
being barbiturates and amphetamines.
1951
Durham-Humphrey Amendment defines
the kinds of drugs that cannot be used
safely without medical supervision and
restricts their sale to prescription by a
licensed practitioner.

1952
In U.S. v. Cardiff, the Supreme Court
rules that the factory inspection provision
of the 1938 FDC Act is too vague to be
enforced as criminal law.
A nationwide investigation by FDA
reveals that chloramphenicol, a broad-
spectrum antibiotic, has caused nearly 180
cases of often fatal blood diseases. Two
years later FDA would engage the
American Society of Hospital
Pharmacists, the American Association of
Medical Record Librarians, and later the
American Medical Association in a
voluntary program of drug reaction
reporting.

1953
Factory Inspection Amendment clarifies
previous law and requires FDA to give
manufacturers written reports of conditions
observed during inspections and analysis of
factory samples.
1955
HEW Secretary Olveta Culp Hobby
appoints a committee of 14 citizens to
study the adequacy of FDA's facilities and
programs. The committee recommends a
substantial expansion of FDA staff and
facilities, a new headquarters building, and
more use of educational and informational
programs.

1962
Thalidomide, a new sleeping pill, is
found to have caused birth defects in
thousands of babies born in western
Europe. News reports on the role of Dr.
Frances Kelsey, FDA medical officer, in
keeping the drug off the U.S. market,
arouse public support for stronger drug
regulation.

1962
Kefauver-Harris Drug Amendments are
passed to ensure drug efficacy & greater
drug safety. For the first time, drug
manufacturers are required to prove to
FDA the effectiveness of their products
before marketing them. In addition, FDA
is given closer control over
investigational drug studies, FDA
inspectors are granted access to
additional company records, &
manufacturers must demonstrate the
efficacy of products approved prior to
1962.

1963
Advisory Committee on Investigational
Drugs meet the first meeting of a
committee to advise FDA on product
approval and policy on an ongoing basis.
1965
Drug Abuse Control Amendments are
enacted to deal with problems caused by
abuse of depressants, stimulants, and
hallucinogens.
1966
FDA made a contract with the National
Academy of Sciences / National Research
Council to evaluate the effectiveness of
4,000 drugs approved on the basis of
safety alone between 1938 and 1962.

1968
FDA Bureau of Drug Abuse Control and
the Treasury Department's Bureau of
Narcotics are transferred to the
Department of Justice to form the Bureau
of Narcotics and Dangerous Drugs
(BNDD), consolidating efforts to police
traffic in abused drugs. A reorganization
of BNDD in 1973 formed the Drug
Enforcement Administration.
FDA forms the Drug Efficacy Study
Implementation (DESI) to incorporate
the recommendations of National
Academy of Sciences investigation of
effectiveness of drugs marketed between
1938 and 1962.

1968
Animal Drug Amendments place
all regulation of new animal
drugs under one section of the
Food, Drug, and Cosmetic Act--
Section 512--making approval of
animal drugs and medicated
feeds more efficient.

1971
FDA requires the first patient package
insert: oral contraceptives must contain
information for the patient about specific
risks and benefits.
The Comprehensive Drug Abuse
Prevention and Control Act replaces
previous laws and categorizes drugs based
on abuse and addiction potential and also
its therapeutic value
1972
Over-the-Counter Drug Review is initiated
to enhance the safety, effectiveness and
appropriate labeling of drugs sold without
prescription.

1973
The U. S. Supreme Court upholds the
1962 drug effectiveness law &
endorses FDA action to control entire
classes of products by regulations
rather than to rely only on time-
consuming litigation.
1976
Vitamins and Minerals Amendments
("Proxmire Amendments") stop FDA
from establishing standards limiting
potency of vitamins & minerals in food
supplements or regulating them as
drugs based solely on potency.

1982
Tamper-resistant packaging
regulations issued by FDA to prevent
poisonings such as deaths from cyanide
placed in Tylenol capsules. The Federal
Anti-Tampering Act passed in 1983
makes it a crime to tamper with
packaged consumer products.
1983
Orphan Drug Act passed,
enabling FDA to promote research and
marketing of drugs needed for treating
rare diseases.

1984
Drug Price Competition and Patent Term
Restoration expedites the availability of
less costly generic drugs by permitting
FDA to approve applications to market
generic versions of brand-name drugs
without repeating the research done to
prove them safe and effective. At the
same time, the brand-name companies
can apply for up to five years additional
patent protection for the new medicines
they developed to make up for time lost
while their products were going through
FDA's approval process.

1987
FDA revises investigational
drug regulations to expand
access to experimental drugs
for patients with serious
diseases with no alternative
therapies.

1988
The Prescription Drug Marketing Act bans
the diversion of prescription drugs from
other commercial channels. Congress finds
that the resale of such drugs leads to the
distribution of mislabeled, adulterated, sub-
potent, and counterfeit drugs to the public.
The new law requires drug wholesalers to
be licensed by the states; restricts re-
importation from other countries; and bans
sale, trade or purchase of drug samples,
and traffic or counterfeiting of redeemable
drug coupons.

1991
FDA publishes regulations to accelerate
reviews of drugs for life-threatening
diseases.
1992
Generic Drug Enforcement Act imposes
debarment and other penalties for illegal
acts involving abbreviated drug
applications.
Prescription Drug User Fee requires drug
and biologics manufacturers to pay fees
for product applications and supplements,
and other services. The act also requires
FDA to use these funds to hire more
reviewers to assess applications.

1994
FDA announces that it could consider
regulating nicotine in cigarettes as a drug,
in response to a citizen's petition by the
Coalition on Smoking OR Health.
Uruguay Round Agreements Act extends
the patent terms of U.S. drugs from 17 to
20 years.
1995
FDA declares cigarettes to be "drug
delivery devices." Restrictions are
proposed on marketing and sales to reduce
smoking by young people.

1997
Food and Drug Administration
Modernization Act reauthorizes the
Prescription Drug User Fee Act of
1992 and mandates the most wide-
ranging reforms in agency practices
since 1938. Provisions include
measures to accelerate review of
devices, advertising unapproved uses
of approved drugs and devices, health
claims for foods in agreement with
published data by a reputable public
health source, and development of
good guidance practices for agency
decision-making.

NDA
NEW DRUG APPLICATION

Introduction:
For decades, the regulation and control of new
drugs in the United States has been based on the
New Drug Application (NDA). Since 1938, every
new drug has been the subject of an approved NDA
before U.S. commercialization. The data gathered
during the animal studies and human clinical trials
of an Investigational New Drug (IND) becomes part
of the NDA.

When the Food, Drug, and Cosmetic Act
(FD&C Act) was passed in 1938, NDAs were
only required to contain information pertaining
to the investigational drug's safety. In 1962, the
Kefauver-Harris Amendments to the FD&C Act
required NDAs to contain evidence that a new
drug was effective for its intended use as well,
and that the established benefits of the drug
outweighed its known risks.

The NDA was again the subject of change in
1985, when the FDA completed a
comprehensive revision of the regulations
pertaining to NDAs. While this revision,
commonly called the NDA Rewrite, modified
content requirements, it was mainly intended to
restructure the ways in which information and
data are organized and presented in the NDA to
easily access FDA reviews.

 As outlined in Form FDA-356h, Application
to Market a New Drug for Human Use Or
As An Antibiotic Drug For Human Use,
NDAs can consist of as many as 15 different
sections:
1. Index
2. Summary
3. Chemistry, Manufacturing, and Control;
4. Samples, Method Validation Package, and
Labeling
5. Nonclinical Pharmacology and Toxicology
6. Human Pharmacokinetics and
Bioavailability 03/22/15www.PharmInfopedia.com

7 Microbiology (for anti-microbial drugs only);
8 Clinical Data;
9 Safety Update Report (typically submitted 120
days after the NDA's submission);
10 Statistical;
11 Case Report Tabulations;
12 Case Report Forms;
13 Patent Information;
14 Patent Certification; and
15 Other Information.
(e.g. the marketing history of the drug (if any)
outside the U.S., a concluding discussion of
benefit/risk considerations and of proposed
additional studies or postmarketing surveillance
plans etc.) 03/22/15www.PharmInfopedia.com

NDA must provide all relevant data and
information that a sponsor has collected during
the product's research and development.
The FDA has numerous guidelines that relate
to NDA content and format issues. These
guidelines can be obtained from CDER's Drug
Information Branch (DIB).

CDER classifies new drug applications with a
code that reflects both the type of drug being
submitted and its intended uses. The numbers 1
through 7 are used to describe the type of drug

1. New Molecular Entity
2. New Salt of Previously Approved Drug (not
a new molecular entity)
3. New Formulation of Previously Approved
Drug (not a new salt OR a new molecular
entity)
4. New Combination of Two or More Drugs
5. Already Marketed Drug Product -
Duplication (i.e., new manufacturer)
6. New Indication (claim) for Already Marketed
Drug (includes switching marketing status
from prescription to OTC)
7. Already Marketed Drug Product - No
Previously Approved NDA

The following letter codes describe the review
priority of the drug:
S - Standard review: For drugs similar to currently
available drugs.
P - Priority review: For drugs that represent
significant advances over existing treatments.

The new (present) NDA regulations require that
an application be submitted in two copies :
(a) an archival copy that serves as a permanent
record of the submission, and
(b) a review copy.
The review copy is made up of a number of
separate technical volumes, each tailored to the
needs of the disciplines involved in the review.
Both the archival and review copies are
submitted in hard copy, the regulations permit
an application to submit the archival copy as
microfiche

The NDA application form (FORM NDA 356
h) consist of :
Twelve items (including index) deals with the
safety and efficacy features of drug product, two
are concerned with patent information.

 The format and content of an application
summary
 Formatting, assembling and submitting
new drug and antibiotic applications
 The submission in microfiche of the
archival copy of an application
 The format and content of the human
Pharmacokinetics and Bioavailability section of
an application
 The format and content of the clinical and
statistical sections of an application. 03/22/15www.PharmInfopedia.com

• The format and content of the
chemistry, manufacturing and
control section of an
application
• Post marketing reporting of
adverse drug reactions

The chemistry section, because of its length, and
highly detailed sections dealing with the
manufacturing and control processes, is required
to be submitted 90-120 days prior to the
submission of the application for facilitating the
identification of deficiencies in the filed NDA.
Submission of chemistry section earlier than 120
days and less than 90 days before the remainder
of the application will not be accepted.

The archival copy of the application should
include a comprehensive index by volume and
page number. It is recommended that additional
copies of the index be prepared and included
with any material submitted to FDA for the
NDA. This will easily access locating important
parts of the submission that may be needed for
meetings / view by individual technical
reviewers.

It has been suggested that the summary consists of
50 - 200 pages. The summary should discuss all
aspects of the application and needs to be written at
approximately level of detail required for
publication and meet the editorial standards applied
by referred scientific and medical journals.
It is advantageous to provide data in the summary in
tabular and graphic form with clear explanation of
any terminology used in the tabulations or graphics.

The required safety data (from view point of clinical
studies, animal studies, other sources generated or
reported to sponsor) must be submitted in same
format as integrated summary of safety described
under clinical data section of the NDA content and
format (21 CFR 314.50). Additionally the NDA
format is required to include case report forms for
each patient who died during a clinical study or who
did not complete the study due to an adverse event.

Safety update reports must be submitted at
(a) 4 months after the initial submission of an
application,
(b) following receipt of an approvable letter
and
(c) other times as requested by the FDA.

Important point is the specific
citation needed for the solid state
forms of the drug substance and their
relationship to bioavailability.
Chemistry, manufacturing and
controls summary must provide a
general overview of the drug
substance and drug product. 03/22/15www.PharmInfopedia.com

Drug substance:
Description including physical and
chemical characteristics and stability
Drug product:
Composition and type of dosage
form, manufacture, specifications and
analytical methods, container/closure
system, stability, investigational
formulations.
Details are provided in 21CFR 25.103/22/15www.PharmInfopedia.com

Nonclinical laboratory studies include any
invivo/invitro experiment with the test drug to
determine its safety, activity or disposition. This
section includes Toxicological effects of drugs on
reproduction and the developing fetus, ADME
animal experiments of the drugs
This section should provide a description,
tabulation and graphics from Nonclinical laboratory
studies of drug.

First section : There should be an overall
tabulated summary of all invivo
biopharmaceutic studies carried out on the drug
grouped by type of study.
Second section : The summary of bioavailability
or pharmacokinetic data and overall conclusions
(Cmax, Tmax, Kel, AUC etc.)

Third section : List of all formulations used in
clinical trials and invivo bioavailability or
pharmacokinetic studies together with each
formulation used in studies.
Fourth section : Analytical methods used to
measure the levels of drug and major metabolite
Fifth section : Dissolution data on each strength
and dosage form for which approval is being
sought. A comparative dissolution study with the
lot(s) used. In vivo biopharmaceutics studies
should also be included.

 Applicable to anti-infective and antiviral
drugs.
 It should include description of :
Biochemical basis of the drug’s action /
microbial physiology.
Antimicrobial spectra of the drug, including
results of invitro preclinical studies that
demonstrate effectiveness.
Any known mechanisms of resistance to the
drug, including results of epidemiological
studies to demonstrate privilege of resistance
factors.
Clinical microbiological laboratory methods03/22/15www.PharmInfopedia.com

This section includes descriptions, summaries
and analysis of :
Clinical pharmacology studies including
animal study and toxicology.
Controlled clinical studies including the
protocol and description of the statistical
analyses used to evaluate the studies.
Uncontrolled clinical studies, including all
necessary details of the studies.
Any other data/information relevant to an
evaluation of safety and effectiveness obtained

Statistics section should include:
A statistical evaluation of the clinical data
 A copy of the data given in the description and
analysis of each controlled clinical study, along
with the statistical analysis.
 A copy of the data included in the integrated
summary of all available information about the
safety of the drug.

Review Time Frames (21 CFR 314.100)
This time frames includes:
Within 180 days of receipt of an application, the
FDA will review and issue an approval,
approvable, or not approvable letter. This 180-
day period is called the ‘review-clock”
During the review period an applicant may
withdraw an application (21 CFR 314-65) and
later resubmit it.
The time period may be extended by mutual
agreement between the FDA and the applicant
or as the result of submission of a major
amendment (21 CFR 314.60)

Filing Time Frames (21 CFR 314.101):
Within 60 days after the FDA receives an
application, a determination will be made
whether the application may be filed.
This will determine whether sufficient
information is provided to proceed with an in-
depth review of application.
If FDA files the application, the applicant will
be notified in written. The date of filing will be
the date 60 days after the FDA received the
application.
The date of filing begins the 180-days period of
the review. If FDA refuses to file the application,
the sponsor will be given the opportunity to meet
with FDA to discuss the reasons why the
application is not fileable. 03/22/15www.PharmInfopedia.com

Clinical data will be considered on merit
regardless of country of origin. Foreign Clinical
data meeting U.S. criteria for approval may be
approved if :
The foreign data are applicable to the U.S.
Population and U.S. Medical practice
The studies have been performed by clinical
investigators of recognized competence
If an inspection is necessary, FDA is able to
validate the data through an on-site inspection or
other appropriate means or the data may be
considered valid without the need for an on-site
inspection by FDA. 03/22/15www.PharmInfopedia.com

FDA will apply this policy according to the
nature of the drug and the data being considered.
The FDA is willing to explore all areas to remove
the need to conduct repetitive clinical testing in
U.S. When adequate foreign data have been
generated a pre-NDA submission meeting is
encouraged when approval being solely on
foreign data is sought.

Approximately 90 days after the NDA is received, the FDA
will provide applicants with an opportunity to meet with
reviewers to discuss the general progress and status of the
application
Particularly for new chemical entities and major new
indications of marketed drugs, this meeting will generally
be held at the applicant’s option and may be held by
telephone.
With the issuance of an approvable/not approvable letter,
an opportunity will be provided to applicants to meet with
the FDA and discuss what further steps need to be taken
before the applications can be approved. Priority for these
meetings will be given to applications for new chemical
entities and major new indications for marketed drugs.

In 21 CFR 314.50 (d) (5) (vi) (b), the FDA
details the necessity to periodically update a
pending application with new safety
information which affects the statements of
contraindications, warnings, precautions and
adverse reactions in the draft labeling. The
safety update reports are required to include
the same kinds of information from clinical or
animal studies as well as other sources, and
must be submitted in the same format as the
previously described integrated summary of
safety. 03/22/15www.PharmInfopedia.com

These safety reports must be
submitted as follows:
 Four months after the initial
submission
 Following receipt of an
approvable letter
 At other times as requested by
FDA

In case of any adverse drug experience, the
surveillance system requires the reporting
of such experience as soon as possible
within 15 working days of initial receipt of
the information. These ‘alert reports’ are
required to be submitted on Form FDA 1639
(Drug Experience Report). All reactions
subject to 15 day alert report require follow-
up reports within 15 working days of receipt
of new information
Even if no such reports are reported, the
follow up reports has to be submitted in
separate cover and as a summary / tabular
form to be presented in periodic report

NDA holders must review
periodically (quarterly for the first
three years and yearly thereafter) the
frequency of adverse drug experience
reports that are serious and
unexpected and report any significant
increase in frequency (e.g. a
doubling) within 15 working days to
determine whether a significant
increase in frequency exists or not.

Applicants must adhere to a
reporting schedule that calls for
submission of each quarterly and
each annual report within 60 days
of the anniversary date of approval
of the application.

A 15-day alert report based on information from
the scientific literature must be accompanied by a
copy of the published article. These literature
reports should be either case reports or the
reporting of a formal clinical trial
Applicants should not include in post-marketing
adverse experience reports of any adverse
experiences that occurred in clinical trials if they
were previously submitted as part of the approved
application.

Following deficiencies are typically encountered in
drug development:
Sponsors do not pursue advice from the FDA
regarding their drug development plan
Sponsors routinely more ahead to the next clinical
trial without completely analyzing results of the
most recent trial
Sponsors sometimes provide a minimal amount of
data in an effort to get drug approvals

Concept: it is designed to shorten FDA review
time by submitting data to FDA in a form ready
for manipulation by a computer.
Importance is given on the clinical sections of
the NDA, as they require the maximum time to
review and often require manipulation of the
data by FDA.

In a September 15, 1988 Federal Register Notice,
FDA stated to increase the use of computers
in field of improving efficiency of the drug
review process. FDA had not provided exact
blue print on how to best organize / submit a
CANDA, but two basis computer systems
have been developed so far:
Involves keeping the data on a mainframe
computer that is operated either by the sponsor /
by the computer company assisting it with FDA
able to access the information via a telephone
connection.
Putting the data on a floppy disk, laser disc, etc.
for use by FDA via desktop computers that are
provided by the sponsor.

One possible concern of CANDAs
is the possibility of ‘data dredging’
by FDA reviewers, that is pursuing
tangential rather than Central
issues because the computer makes
it easy to do so, but this has not
been observed routinely.

Be sure to supply additional (desk copy)
submissions of the clinical data section and
integrated summaries of safety and efficacy for
the medical reviewer; the pharmacokinetic and
bioavailability summary for the
biopharmaceutics reviewer; the chemistry,
manufacturing, and control process summary for
the statistician reviewer; and extra copies of draft
labeling for the medical reviewer.
The submission should be placed in a proper
jacket binders: use the proper numbering system

If requested, be prepared to submit for
review draft copies for advertising and
promotional material to be used in the
initial or launch campaign to the Division of
Drug Advertising and Labeling (HFN-240).
Place the IND, NDA, or petition number on
every letter or submission: include
supplement numbers where applicable.

Submit new information in reviewable bundles
or marketed with references suitable to all the
material FDA reviewers need to consider in
making a decision – this will help avoid lengthy
file searches.
FDA files are chronological: submissions stating
“this replaces, corrects, or up-dates section or
page so-and-so,” do not fit well in the FDA
document-tracking or review system.

It is noteworthy to be familiar with the regulations
applicable to the NDA. The general NDA requirements
are coded in Title 21, Code of Federal Regulations, Part
314.
Subpart A contains the general provisions, section 314.1 to
314.3
Subpart B details the sections for applications as follows:

a. Application
b. Index
c. Summary
d. Technical Sections
1. Chemistry, manufacturing and controls
2. Nonclinical pharmacology and toxicology
3. Human pharmacokinetics and bioavailability
4. Microbiology
5. Clinical data
6. Statistical
e. Samples and labeling
f. Case report forms and tabulations
g. Other 03/22/15www.PharmInfopedia.com

•www.fda.gov/cder/about/history/time1.html
•Remington: The Science And Practice Of
Pharmacy, 20th edition, Lippincott,Williams &
Wilkins, page no: 930-943
•New Drug Approval Process: second edition,
revised and expanded, edited by Richard A.
Guarino page no: 39-64, 243-263

• www.fda.gov/cder/handbook/ndabox.htm
• www.fda.gov
• www.phrma.org

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