FDA Law Blog: Biosimilars

MAY 19, 2024

By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations.

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FDA Law Blog: Biosimilars

JULY 17, 2024

These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).

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pharmaphorum

OCTOBER 7, 2020

Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects. Workshop: October 30th, 2020.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.

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FDA Law Blog: Biosimilars

MAY 4, 2023

For example, in March 2023, FDA issued a Framework for the Use of Digital Health Technologies in Drug and Biological Product Development , which noted that FDA would publish guidance on the use of DHTs in both traditional and decentralized clinical trials.

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FDA Law Blog: Biosimilars

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2024

CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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