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Lowell Zeta

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JPM2024: What to expect from FDA in an election year

Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs for advanced medicines using innovative...more

1/5/2024  /  Biologics , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Unapproved stem cell therapies remains a top FDA enforcement priority

Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping...more

6/17/2022  /  Center for Biologics Evaluation and Research (CBER) , Enforcement Actions , Enforcement Priorities , False Claims Act (FCA) , Food and Drug Administration (FDA) , Grace Period , Life Sciences , Pharmaceutical Industry , Warning Letters

FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience - Long-Awaited ICH Q13 draft...

Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more

8/24/2021  /  Biologics , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , CGMP , Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Prescription Drugs , Supply Chain

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

7/14/2021  /  Biotechnology , Center for Biologics Evaluation and Research (CBER) , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Grace Period , Life Sciences , Pharmaceutical Industry , Regenerative Medicine

Time’s up: New enforcement era for regenerative medicines begins June 1 - CBER reiterates May 31 end for HCT/P compliance “grace...

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they...more

5/10/2021  /  Biologics , Biotechnology , Center for Biologics Evaluation and Research (CBER) , Clinical Trials , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Life Sciences , Pharmaceutical Industry , Regenerative Medicine , Regulatory Standards
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