Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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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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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

. § 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Eur Respir J 2014; 43: 343–73. NPJ Prim Care Respir Med 2014; 12; 24: 14009. 2014; 133: 388–94. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. EMJ Allergy Immunol.

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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. 2, 2014), [link]. [12] In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] 31, 2023), [link]. [10] 11] Jeffrey N. Gibbs, Allyson B.

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Agency IQ

SEPTEMBER 29, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

JUNE 2, 2023

These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

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