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02

Feb

USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.

Over the past year, FDA has placed pressure on foreign drugmakers to bring their manufacturing into the U.S. FDA Commissioner Marty Makary posted his Top 10 accomplishments recently, and promoting domestic production was among them. This followed similar remarks at the 2026 J.P. Morgan Healthcare Conference. FDA’s regulatory policies here are in service of a merger of drug quality, international trade, and national security to address concerns that foreign drug manufacturing poses threats to American consumers.,,[FDA]

23

Apr

Top Drugs at Risk of Supply Shortages

Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...

23

Apr

Regulatory considerations for pharmaceutical excipient selection

The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...

21

Apr

TGA clarifies therapeutic goods are unaffected by chemical production and import ban

TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...

20

Apr

US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics

FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...

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