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Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell...
BioresearchOnline· 3 days agoIn April 2024, the U.S. FDA released the draft guidance for industry Considerations for the Use of...
Health Care: Republicans scrutinize FDA
Axios· 4 days agoThe FDA's drug approvals and oversight of lab-developed tests are again emerging as hot topics as House Republicans crank up oversight of the agency and...
Mirat Shah, MD, on Elacestrant's FDA Approval for Breast Cancer With ESR1 Mutations
MedPage Today· 5 days agoFDA scientists published a detailed rationale for the approval of elacestrant (Orserdu), the first...
Exact Sciences stock drops as Guardant Health test supported by FDA panel
Investing.com· 2 days agoExact Sciences stock drops as Guardant Health test supported by FDA panel
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 5 days agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
FDA Advisors Not Convinced Once-Weekly Insulin Is Safe in Type 1 Diabetes
MedPage Today· 2 days agoAn FDA advisory committee mostly agreed on Friday that an investigational once-weekly insulin...
Indica Labs’ HALO AP Dx platform receives FDA 510(k) clearance
Medical Device Network via Yahoo Finance· 3 days agoIndica Labs has received 510(k) clearance from the US Food and Drug Administration (FDA) for its...
FDA approves CorTec’s implant system for stroke rehabilitation study
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has granted approval for an investigational device...
FDA lifts partial clinical hold on Larimar’s Friedreich’s ataxia treatment
Endpoints News· 5 days agoLarimar Therapeutics’ stock $LRMR shot up by as much as 20% after announcing Monday that the FDA had...
Michael Druckman on Food and Drug Administration (FDA) | JD Supra
JD Supra· 3 hours agoJD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations. This Privacy Policy describes how JD Supra ...
