Manufacturing
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Brand Drug Shortages Complicate US FDA Messaging To Congress
The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different.
Pharma Facing Growing Risks From Geopolitics, Industry Leaders Warn
Industry leaders and experts at the Financial Times Pharma and Biotech Summit said the US relationship with China adds pressing risk to pharma.
Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity
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.
As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs
Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.
UK Subscription Contracts Will Target Antimicrobials Against ‘Critical’ Pathogens
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.
US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals
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.
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.
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