A presentation on NDA/BLA/PMA and 510(k)

1. NDA/BLA/PMA and 510(k)
Presented by:
Polishetty Navalika
M-Pharmacy
(Pharmaceutics)

3. RELEVANT LAWS
Federal Food, Drug, and Cosmetic Act .
Public Health Service Act-Part F Licensing of
biological products and Clinical Laboratories.

4. RELEVANT REGULATIONS
IND regulations (both drug and biologics)21
CFR 312.
NDA (drug) regulations--21 CFR 314.
Product licensing (biologics)—21 CFR 601.
Protection of human subjects and informed
consent regulation—21 CFR 50.
IRB Regulations—21 CFR56

6. NEW DRUG APPLICATION
Since 1938 every new drug has been the
subject of an approved NDA before U.S
commercialization.
The NDA application is the vehicle through
which drug sponsors formally propose that the
FDA approve a new pharmaceutical for sale and
marketing in the U.S.
The data gathered during the animal studies
and human clinical trials of an investigational
New Drug (IND)become part of the NDA.

7. GOLES OF NDA
Safety and effectiveness of a new drug in its
proposed use(s).
Whether the drug’s proposed labeling
(package insert) is appropriate.
Methods used in manufacturing the drug
and the controls used to maintain the drug’s
quality are adequate to preserve the drug’s
identity, strength, quality, and purity.
The benefits of the drug outweigh the risks.

8. BASIS FOR NDA APPROVAL
Demonstration of efficacy with acceptable
safety in adequate and well-controlled studies
Ability to generate product labeling that
-Defines an appropriate patient
population for treatment with the drug.
-Provides adequate information to
enable safe and effective use of the drug.

9. The IND and NDA process
Drug development
-preclinical
-phases i, ii, iii
-plan with the indication/market in mind
FDA interactions
-Communication
-Meetings
-Submission
All aspects considered simultaneously

16. Biologics license application (BLA)
The biologics license application is a request
for permission to introduce, or deliver for
introduction, a biologic product into
interstate commerce (21 CFR 601.2).
The BLA is regulated under 21 CFR 600 – 680.

18. BASSIS OF BLA APPROVAL
Licence granted for products that meet
standards designed to insure “continued safety,
purity, and potency” of the product.
“potency” interpreted as “efficacy”
42 USC section 262
21 CFR 600.3(s)

23. NDA and BLA Application
NDA and BLA are applications to market
a new product. NDAs are used by
CDER(center for drugs) and BLAs are
used by CBER(center for biologics) .

29. Premarket Approval (PMA)
Premarket approval (PMA) is the FDA process of
scientific and regulatory review to evaluate the
safety and effectiveness of Class III medical devices.
Class III devices are those that support or sustain
human health.
Due to the level of risk associated with Class III
devices, FDA has determined that general and
special controls alone are insufficient to assure the
safety and effectiveness of class III devices.
Therefore, these devices require a premarket
approval (PMA) application under section 515 of the
FD&C Act in order to obtain marketing clearance.
Please note that some Class III preamendment
devices may require a Class III 510(k).

30. PMA application methods
Traditional PMA
Modular PMA
Streamline PMA
Product Development Protocol

34. 510(K)
In order to legally sell or distribute Class II but also some Class
I and Class III medical devices in the U.S., manufacturers must
first obtain clearance for their device from the FDA.
In order to obtain clearance, manufacturers are required to
submit a 510(k) premarket notification. Manufacturers are also
required to file a 510(k) submission in cases where a previously
cleared device has been modified in a way that its safety or
effectiveness might be affected.
 A 510(k) submission is based on comparison of the new
device with devices already legally marketed in the USA, which
allows the US Food and Drug Administration (FDA) to determine
whether a device is safe and effective.

35. PMA vs 510(K)

36. Medical Devices Classification