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.

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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.

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The Pharma Data

SEPTEMBER 17, 2020

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. government, we could become subject to significant sanctions.

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Agency IQ

JULY 8, 2024

Coming up is publication of the amendments to the IVDR and MDR, that would postpone the final IVDR compliance date for diagnostics that qualify for the extension, allow for a phased rollout of EUDAMED and would require manufacturers of certain devices to notify regulators and clients of upcoming shortages.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Agency IQ

OCTOBER 27, 2023

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

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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.

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FDA Science Biosimilars Clinical Trials 40

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 (..)

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Biosimilars Science Clinical Pharmacology FDA 40

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. is the largest dedicated food and drug law firm in the country.

Science 40

Science Government FDA Regulations 40

Agency IQ

DECEMBER 1, 2023

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

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FDA Science Regulations Production 40