Manufacturing

Industry leaders and experts at the Financial Times Pharma and Biotech Summit said the US relationship with China adds pressing risk to pharma.

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.

Pharma companies seeking a subscription-style contract for new antimicrobials will need to meet a number of requirements, such as guaranteeing surety of supply, meeting key performance measures and complying with specified manufacturing standards.

CBER’s Nicole Verdun said the FDA is using the principles of the platform approach in situations that don’t qualify for the agency’s new incentive.

US FDA Principal Deputy Commissioner Namandjé Bumpus recently attended a biotech-themed roundtable with the Senate Select Committee on Intelligence and national security officials as Congress’ pulls the FDA into its worries about Chinese influence of the pharma industry.

But that clock is already ticking as the House Oversight and Accountability Committee prepares to mark-up the bill and a likely reconciliation effort with the Senate looming.

Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.’

As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.

The FDA drug center director is encouraging manufacturers to contact the agency’s shortage surveillance team before making rash decisions during or right after an inspection. 

The US FDA’s Office of Regulatory Affairs is facing challenges in retaining and hiring new staff, which will impact inspections, ORA chief Michael Rogers said. 

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

Developing drugs for some rare diseases is “just not commercially feasible,” meaning that alternative approaches, such as funding through venture philanthropy and not-for-profit models, need to be explored, a gene therapy professor has said.

The Swiss agency says the aim of the agreement is to bring “high-quality, life-saving medicines to patients as quickly as possible.”

The US FDA's controversial final rule places laboratory developed tests under same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.

ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.