Changes to the procurement of critical medicines and their active ingredients are among the amendments the Council of the EU has made to the draft Critical Medicines Act.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
The FDA wants to charge a yearly fee after an IND is filed for firms that do not conduct Phase I clinical studies in the US as part of its proposal to encourage more domestic development.
The UK’s autumn budget failed to introduce any widespread changes for pharma, but scale-ups and innovators could benefit from changes to enterprise and investment schemes. Some industry voices warn of underinvestment in the MHRA and innovative medicines.
The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.
A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.
New Zealand is also lifting its prohibition on advertising unapproved medicines at medical conferences and trade shows in order to boost its appeal as a host for such events and generate millions of dollars in revenue.
‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.
Pfizer, which markets Vyndamax for transthyretin amyloid cardiomyopathy, said an FDA violation letter shows BridgeBio made false and misleading superiority claims, but BridgeBio refused to participate in the National Advertising Division process.
Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.
The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.
New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.
Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.
Experts from UCB, Alnylam, Lantheus and Medtronic deliberate on the best use of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny
Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.
The first round of ad/promo violation letters largely left social media untouched despite a vow to go after “dark ads” and violative influencer claims. Industry wants more information on the new, de facto standards suggested in the initial DTC and healthcare provider promotion letters.
Pink Sheet reporter and editors discuss the FDA’s plans to undo a previous reorganization and make facility and other inspectors generalists again, as well as industry efforts to adapt to the new direct-to-consumer advertising landscape.