Manufacturing

The UK’s roadmap for reducing animal testing is a positive starting point, but greater transparency from the drug regulator and a more detailed workplan from government will be required to make the plans a reality, an expert from Cruelty Free International says.

Limited visibility into the FDA’s use of remote regulatory assessments and the lack of a clearly defined closeout process leave companies uncertain about outcomes and expectations, industry experts say.

Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.

Former agency officials who now represent industry worry that a deregulatory bent could be driving the "Simple Reform" plan to merge all medical product and clinical research inspectorates and that the specialist expertise gained in the 2017 "Program Alignment" initiative will be reversed.

Facilities that are not ready for an inspection can lead to delays in the FDA’s site assessment and leave little time to resolve deficiencies ahead of a user fee goal, CBER compliance office Director Melissa Mendoza said.

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.

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.

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.

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.

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.

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.

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.

The Therapeutic Goods Administration has been receiving an increasing number of applications from bacteriophage therapy manufacturers who want to supply unapproved products.