FDA Law Blog: Biosimilars

MARCH 4, 2024

Failure to provide notification of a discontinuance or interruption to FDA potentially could, among other things, land a manufacturer on the Drug Shortages: Non-Compliance With Notification Requirement website. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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FDA Law Blog: Biosimilars

JUNE 17, 2024

Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA). The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

Factor B was the pharmacy’s experience with dispensing or conducting research with respect to controlled substances while Factor D was compliance with applicable state, federal, or local laws relating to controlled substances. 21 U.S.C. § 823(g)(1)(B), (D). at § 64B16-27.800(2).

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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

JULY 27, 2021

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Revenue outside the U.S. decreased 28 percent to $95.6

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Audits and Compliance Monitoring: Using its discretionary authority under 42 U.S.C. CMS may similarly audit participating manufacturers up to once a year to monitor their compliance after a similar 60-day notice of a reasonable basis for the audit. Final Guidance at 15.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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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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Agency IQ

SEPTEMBER 29, 2023

The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

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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. Priority B List.

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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., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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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. The following PDUFA dates were obtained from publicly available sources.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] By their very nature, these tests are less likely to be exempt from FDA review.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

OCTOBER 29, 2020

Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

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The Pharma Data

SEPTEMBER 16, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

SEPTEMBER 20, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions.

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The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions.

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The Pharma Data

APRIL 27, 2021

reflecting lower treatment compliance during the COVID-19 pandemic. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). First-quarter Fabrazyme ® sales increased 4.7% In the U.S. sales decreased 2.9% Net sales (€ million). Fasturtec ®.

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Agency IQ

SEPTEMBER 1, 2023

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. The procedure is available for E.U. Japan, Switzerland, Singapore and the U.S. market more quickly. or E.A.A.

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FDA Law Blog: Biosimilars

JANUARY 9, 2024

This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. based entity licensed as a wholesale distributor or a pharmacist that will import the drugs. This must be a U.S.-based Proposed relabeling and proposed NDC numbers for the drugs to be imported.

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FDA Law Blog: Biosimilars

MAY 5, 2024

OASH concluded “there is widespread current experience with medical use in the United States” by licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine in these states.” Congress has enacted a number of CSA provisions to ensure compliance. 21 U.S.C. §

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