Manufacturing
The threat of Chinese dominance in the prescription drug sector appears to be a strong, unifying theme for legislators heading into the US Food and Drug Administration user fee reauthorization cycle, but two very different sets of policy issues must be addressed.
The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.
Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.
Lawyers from Sidley Austin tell the Pink Sheet how European drug manufacturers and marketing authorization holders should proactively deal with warning letters from the US Food and Drug Administration.
The agency offered to drop annual IND fees for sponsors not conducting Phase I trials in the US, but industry still raised several concerns about fee incentives for onshoring clinical development.
Vaccine manufacturers warned the FDA vaccines advisory committee that international genetic resource rules are delaying influenza virus sharing and creating regulatory hurdles that could undermine seasonal vaccine preparedness.
The FDA's widely referenced scale-up and post-approval changes (SUPAC) guidelines could be modernized to acknowledge evolving science and conflicts with newer recommendations.
Trivalent formulations for the 2026-2027 northern hemisphere flu season address the swift rise of subclade K, but the persistent need for broader antigen coverage keeps quadrivalent possibilities in mind.
CMS is proposing enhanced payments for hospitals that commit to purchasing essential medicines from domestic sources, but wants ideas for defining a “domestic” medicine.
The FDA offered to relax the onshoring criteria to receive a priority ANDA review in GDUFA IV, but could drop another America First proposal.
Pink Sheet editors, as well as Michael Rogers and Douglas Stearn of Canal Row Advisors, discuss short- and long-term issues with the US FDA’s inspection staff and approach.
Designation of more regulatory resources by China’s top drug regulator to the cell therapy sector appears key to the recent consecutive release of guidelines related to CAR-T products in the country.
The EU should focus on supporting the development of collaborative hubs that underpin global excellence in translation, manufacturing and commercialization of advanced therapy medicinal products to keep pace with the US and China, a senior figure from Bayer says.
Platform technologies in the EU are set to benefit from greater regulatory flexibility under the upcoming EU pharma legislation overhaul. Industry is urging policymakers to “avoid misalignment” with other global regulators, including in the US.
Industry continues to oppose domestic manufacturing incentives that the FDA wants to include in the PDUFA reauthorization.
In 2026, the Danish inspectors plan to focus on whether drug manufacturing procedures still match the approved marketing dossier, and will require wholesalers to show that the computerized systems used in distribution are fit for purpose.
The Sec. 232 tariffs, which still could be imposed on pharma and other industries, remain a threat despite the US Supreme Court decision striking down President Trump’s International Emergency Economic Powers Act tariffs.
Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.
User fee program changes traditionally are technical and FDA-specific, but the Trump Administration appears to also want policies advocating its “America First” agenda included.
Pharmaceutical companies are already adapting their existing processes to align with and implement a new global standard for evaluating the environmental impact of pharmaceutical products.