Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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Development Bioequivalency Generic Drugs Production 242

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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Bioequivalency Production Branding Contamination 130

FDA Law Blog

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” FDA explained that its bioequivalence regulations at 21 C.F.R. FDA borrowed this definition from 21 C.F.R.

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Production Bioequivalency Drugs Containment 59

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not. Quitting smoking is an arduous, exhausting process. However, it is possible.

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Marketing FDA Approval Branding Production 52

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline.

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Trials Medicine Production Containment 52