The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.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.
After mandating mail back envelopes be available, the FDA now is considering whether disposal options that would allow opioids to be thrown in the trash also should be required, potentially adding to the expense for sponsors.
EU data protection bodies back clinical trial harmonization under the draft Biotech Act, but insist on strong safeguards for sensitive health data.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
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.
An Ozempic DTC video attempts to use humor and contrasting colors to suggest Novo Nordisk's drug has superior efficacy to other GLP-1s, while a J&J commercial mischaracterizes Tremfya clinical data on endoscopic response and remission, the agency said.
CMS is proposing enhanced payments for hospitals that commit to purchasing essential medicines from domestic sources, but wants ideas for defining a “domestic” medicine.
Greater alignment between the EU and Switzerland as part of a new political deal is a positive move for collaborative research and the pharma supply chain, according to industry association EUCOPE.
Nearly 50 medicines are now included in a Nordic pilot that relaxes language requirements on packaging to help improve access to essential hospital treatments.
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.
An EU group of industry experts has issued “pragmatic” best practice recommendations to help sponsors create clear, fully accessible and standardized lay protocol synopses, meeting key transparency obligations of the Clinical Trials Regulation.
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 FDA final rule gives stakeholders seven years to implement the changes, extending the five years previously proposed, but industry wanted more than a three-year transition period after the effective date.
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.