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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. What does it mean for FDA staff?

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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Regulatory considerations for biosimilar clinical efficacy trials

Drug Patent Watch

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Companies Shipping Chemicals: “Know the One You’re Dancing With”

FDA Law Blog: Biosimilars

1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China.

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GAO Report Recommends Retaining FDA’s Drug Inspectional Workforce As Agency Prepares for Trumpian Changes

FDA Law Blog: Biosimilars

But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FDA is already facing a massive inspectional backlog. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr.,

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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law Blog: Biosimilars

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. Wise government officials will modulate their views as they learn new facts. for Secretary of Health and Human Services (HHS).

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