Manufacturing
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Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity
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.
BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’
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.
BIO Seeks ‘Substantial Runway’ To Shift Away From China As Momentum For Manfacturing Bill Grows
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.’
Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says
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.
Don’t Stop Manufacturing Because Of An Inspection, FDA’s Cavazzoni Says
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.
ORA Chief Says Inspections In Jeopardy Without Additional Funding
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.
US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg
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.
Not-For-Profit Models Needed For Commercially Unviable Rare Disease Drugs
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.
Swissmedic Gets New Grant For Regulatory Strengthening In LMICs
The Swiss agency says the aim of the agreement is to bring “high-quality, life-saving medicines to patients as quickly as possible.”
It’s Official: FDA Drops Final Rule On LDTs
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 Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages
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.
EU Countries Offered Funding To Contribute to African Regulatory Strengthening
Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.
WHO Launches Twin-Track Procedure To Speed Access To Health Products
A procedure used to accelerate the approval of COVID-19 products during the pandemic is to be applied to all medicines using “synchronized and parallel, but otherwise entirely independent, processes,” the World Health Organization says.
Germany Promises Harmonized ATMP Rules & More Flexibility For Decentralized Trials
Industry is wary of a provision in Germany’s medical research bill that would introduce standard clauses in the contracts agreed between trial sponsors and study sites.
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