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44 BioPharm International eBook September 2019 www.biopharminternational.com
Regulatory Sourcebook
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The following are some of the notable
regulatory and standard setting resources,
guidance documents, and guidelines.
Resources, Guidelines,
and Guidance Documents
UNITED STATES
The following are some key websites
addressing regulatory requirements for
biologics and other drug products*.
FDA.gov
• Vaccines, Blood, and Biologics
• G u i d a n c e , C o m p l i a n c e , &
Regulatory Information
• FDA Guidance Documents
• FDA Regulatory Science
• F DA Compl ia nce Ac t ions a nd
Activities
• FDA Warning Letters
Additional Resources
• Federal Register
• Federal Code of Regulations
FDA Guidance Documents
FDA's website provies a variety of
regulatory resources including its list
of current guidance documents. The
following are some relevant guidance
documents published in 2018 and
2019.
Final Guidances
• Postmarketing Safet y Reporting
f o r C o m b i n a t i o n P r o d u c t s :
Guidance for Industr y and FDA
Staff
• Population Pharmacokinetics
• Considerations in Demonstrating
I n t e r c h a n g e a b i l i t y W i t h a
Reference Product
• O n c o l o g y P h a r m a c e u t i c a l s :
Reproductive Toxicity Testing and
Labeling Recommendations
• R E M S: F DA's A ppl ic at ion of
Statutory Factors in Determining
When a REMS Is Necessary
• Pediatric Information Incorporated
Into Human Prescription Drug and
Biological Products Labeling Good
Review Practice
• Providing Regulatory Submissions
i n E le c t ron ic For m at– C er t a i n
Human Pharmaceutical Product
A p p l i c a t i o n s a n d R e l a t e d
Subm is sions Usi ng t he e C T D
Specifications
• I m m u n o g e n i c i t y Te s t i n g o f
Therapeutic Protein Products—
Developing and Validating Assays
for Anti-Drug Antibody Detection
• Labeling for Human Prescription
D r u g a nd Biolog ic a l Pro duc t s
Approved Under the Accelerated
Approval Regulatory Pathway
• Data Integrit y and Compliance
W i t h C u r r e n t G o o d
Manufacturing Practice
• A d v e r s e Ev e nt R e p or t i n g for
O ut s o u r c i n g Fa c i l it i e s Un d e r
Section 503B of the Federal Food,
Drug, and Cosmetic Act
• ANDA Submissions–Content and
Format of Abbreviated New Drug
Applications
• Elementa l I mpu r it ie s i n D r u g
Products
• Labeling for Biosimilar Products
FDA Draft Guidances
• D e v e l o p m e n t o f T h e r a p e u t i c
Protein Biosimilars: Comparative
Analytical Assessment and Other
Quality-Related Considerations
• N o n p r o p r i e t a r y N a m i n g o f
Biological Products: Update
• Q u a l i t y C o n s i d e r a t i o n s f o r
Continuous Manufacturing
• Competitive Generic Therapies
• REMS Assessment: Planning and
Reporting
• B i o m a r k e r Q u a l i f i c a t i o n :
Evidentiary Framework
• New and Revised Draft Q&As on
Biosimilar Development and the
BPCI Act (Revision 2)
• Pro duc t Ident i f ier s u nder t he
Drug Supply Chain Security Act–
Questions and Answers
• Postapprova l Cha nges to Dr ug
Substances
Pending Guidances
A list of the guidance documents FDA
has planned for publication can be
found at www.fda.gov/media/124386/
download.
