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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

Ukraine Invasion Challenges Biopharma Research and Operations

Califf will face challenges that include COVID-19, opioids, and user fees.

A Rocky Road Ahead for Commissioner Califf 

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards. 

FDA Nixes Approvals Based Only on Foreign Data

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

FDA Faces Huge Task Catching Up on Inspections

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Politics Impact FDA

The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products

Pandemic Preparedness Legislation Bolsters FDA Oversight

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval  process. 

Concerns Mount over Limited Evidence for Accelerated Approvals

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

FDA Keeps New Drugs Coming

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible. 

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