Switzerland’s regulatory authority for devices and drugs, Swissmedic, decided to revamp how it organizes its postmarket surveillance work, and is also seeking to stand up its medical product surveillance database.
Sana Biotechnology Inc. has obtained FDA clearance of its IND application to conduct a study of SC-262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed chimeric antigen receptor (CAR) T therapy.
The U.S. FDA might still be seen as the premier med tech regulatory entity in the world, but the agency is badly outnumbered by companies in the life sciences, which are pumping out artificial intelligence algorithms at a breathtaking pace. Further, the FDA must also avoid being lapped by industry in connection with the regulatory novelty known as the predetermined change control plan, a challenge that put the agency’s device center in scramble mode for essentially the entirety of calendar year 2023.
Onquality Pharmaceuticals LLC has obtained IND clearance from the FDA for OQL-025 to treat epidermal growth factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy for various cancers.
Quanta Therapeutics Inc. has announced progression of its pipeline of KRAS-directed drug candidates, with the receipt of IND approval from the FDA for QTX-3034.
Are there other guidances the U.S. FDA should release as final without going through the draft and public comment process first? That’s one of the questions the FDA wants stakeholders to comment on as it updates its best practices for guidance.
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocomposites, Ingelheim, Immunexoress, Irhythm, Kuros, Mentice, Renovos, Simbiosys.
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