Agency IQ

JUNE 9, 2023

Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. Generic and biosimilar developers benefit from earlier market entry.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA 40

FDA Science Regulations Production 40

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

Clinical Trials 52

Clinical Trials Drug Development Trials Biosimilars 52

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

The following legislative requirements are due within the next two months: Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.”

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Title Type Comments Close Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop RFI November 30 Medical Devices; Laboratory Developed Tests Rule December 4 Stimulant Use Disorders: Developing Drugs for Treatment Guidance December 4 Modernizing the Food and Drug Administration’s Premarket Notification Program Notice December (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” That would leave 19% of staff affected by furloughs.

FDA 40

FDA Science Biosimilars Regulations 40