The FDA Law Blog

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984. And CVM certainly exercises that authority.

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Pharmaceutical Technology

JULY 14, 2022

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Covid-19 vaccines stay in the spotlight.

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Pharmaceutical Technology

NOVEMBER 30, 2022

These contracts involve the manufacturing of biological and small molecule active pharmaceutical ingredients (APIs), parenteral manufacturing and packaging, and other manufacturing-related tasks. Also in September, the US FDA expanded Sanofi / Regeneron Pharmaceuticals’ Dupixent (dupilumab) label to include prurigo nodularis.

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PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). LinkedIn Total experience: 26 yrs.

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pharmaphorum

MAY 26, 2022

The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus. Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The pandemic brought imbalances into sharp focus. About the authors.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. It is considered a moderate change by the FDA (CBE30) and NMPA.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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