FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

Documentation 144

Documentation Labelling Drug Development 144

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Biosimilars Drug Pricing Packaging Labelling 130

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Drug Development 64

Drug Development Communication Labelling 64

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014. The Role of Master Protocols in Pediatric Drug Development. Ther Innov Regul Sci.

Labelling 59

Labelling Compounding Drug Development 59

Pharmaceutical Technology

JUNE 12, 2023

However, side effects known as amyloid-related imaging abnormalities, which often involve brain swelling, were also reported, and consequently the treatment has a warning on this specific side effect on its label. Leqembi is the second drug developed by Biogen and Eisai for the treatment of Alzheimer’s disease.

Medical Schools 52

Medical Schools Labelling Drug Development 52

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98