USFDA product registration guidelines
The
USFDA is a scientific, regulatory and public health agency that jurisdiction
encompasses on most food products (other than meat and poultry), human and
animal drugs, therapeutic agents of biological origin, medicinal devices,
radiation-emitting products for consumer, medical occupational use, cosmetics
and animal feed.
The
Office of the Commissioner heads the organization under which there are four
departments overlooking management, health, and science, international
activities and regulatory affairs.
TYPES
OF CERTIFICATIONS
The
generic makes one of 4 certifications for each patent:
Paragraph
(I):
That no patent information on that brand name drug has been submitted to the
FDA.
Paragraph
(II): That the listed patent has expired.
Paragraph
(III): That the listed patent will expire on a certain date,
before which time the generic will not enter the market.
Paragraph
(IV): That the patent is invalid or will not be infringed
by the manufacture, use, or sale of the new drug for which the ANDA was
submitted.
When
the generic makes a paragraph I or II certification, the FDA may approve its
ANDA immediately.
The
FDA may approve a paragraph III certification any time after the patent's
expiration date.
The
implications of a paragraph IV certification are not nearly as simple Generic
Drug Product Registration Requirements in the USFDA.
1. The
eCTD is mandatory for the submission of the drug applications (NDA/ANDA).
2. US
FDA guidance (CFR) documents and FDA sections (e.g. 505 (b) for NDA and 505(j)
for -ANDA) are followed for the preparation of the dossier for the drug
approval applications.
3. The
applications are different as follows:
For
new drug-NDA
For
generic drug – ANDA
For
biological application - BLA
4. The
applicant himself or a GDEA (Generic Drug Enforcement Act) certified and
approved agent may directly submit the application to the FDA.
5. Administrative
information is different from a cover letter, forms (356h), application
information, field copy certification, debarment certification, financial
certification, Patent information, and exclusivity.
6. The
paper size for the submission is Letter size (8.5x11 inches) with font size 12
in times new roman format. The tables and figures have small font size i.e. 8
to 10.
7. Package
inserts are provided for drug product in labeling
8. Proposed
Labels and cartons with proper dimensions similar to that of the RLD (Reference
Listed Drugs) labels are provided.
9. The
information about the clinical investigators is provided in Module 5 and in
financial disclosure Statement section of this module.
10. Request
for waiver of in-vivo BE studies is provided in module 1.
11. Annotated
draft labeling (side by side) for labels and cartons compared with the RLD with
proper annotation is provided.
12. The
EAS (Environment Assessment Statement) for categorical exclusion certification
in compliance with the law of EPA (Environment Protection Act) of US is
provided.
13. Risk
management Plans section is for the post marketing surveillance and controlling
the adverse effects of the drugs by proper management. This is the part of
Clinical Trial Phase IV.
14. The
declaration is given for the residual solvent’s limits used or present in the
drug substance and excipients according to the USP.
15. Information
on components including the name and address of the supplier or manufacturer of
the raw material, package material etc. provided in the 3.2.R format.
16. Certificate
of suitability (CEP certificate) is not applicable.
17. Comparability
protocols are not attached to both the drug substance and drug products.
18. The
stability data for accelerated studies are submitted for three months at the
time of original submission.
19. Structured
product labeling (SPL) and study tagging file (STF) is mandatory by the USFDA in
eCTD of a drug registration application
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