The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.
During a virtual appearance at a CERSI meeting two days after announcing retirement plans, the CDER director also said she wished agency reviews of unapproved drugs could be published.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
Now that one of the most controversial pharma M&As of 2024 has closed, the Pink Sheet looks at whether overtures to concerned customers and extended prenotification discussions helped Novo and Catalent seal the deal.
Viatris’ oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.
Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.
The agency’s compliance directors also discussed expectations for greater inspection and review efficiencies as part of the 1 October reorganization during a recent FDLI conference.
Canada’s health products regulator is inviting feedback on a range of new and revised guidelines and regulatory tools that explain how drug and device companies will be able to comply with significant changes proposed to its shortages framework.
Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.
The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.
Compounding pharmacies have 60 days, and outsourcing facilities 90 days, to transition patients to branded products.
Efforts to de-risk the pharma supply chain’s reliance on China likely will not completely disappear if the BIOSECURE proposal dies.
Marketing authorization holders are being encouraged to insert their data on shortages of centrally authorized medicines in the new platform before it becomes mandatory to do so in February 2025.
An FDA complete response letter followed a bioresearch warning letter citing the integrity of electronic data capture and handling of dosing errors in a pivotal trial of govorestat for galactosemia.
Drug companies are being invited to participate in a new pilot project that the five Nordic countries will run to see if they can improve the availability of certain critical products that are used in hospitals.
More than 90% of companies have submitted new medicines packaging artwork to the UK’s drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its 31 December deadline to comply with the new Windsor Framework arrangements.
India continues to reform biopharma regulatory processes and widen digitization efforts. The regulator will curb "re-deliberations" at subject expert committee meetings unless applicants furnish new data.
Vital discussions are ongoing over which medicines containing per- and polyfluoroalkyl substances should be exempt from forthcoming wide-reaching EU restrictions on these substances.
The International Council for Harmonisation is seeking input from IT vendors on what it will take to establish a state-of-the-art technology platform that drug sponsors can use to submit quality-related post authorization submissions for collaborative assessment by multiple regulatory authorities.
Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.