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More Info on Quality Manufacturing Maturity

[ Price : $8.95]

FDA provides additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturi...

Generic Drug Controlled Correspondence Guidance

[ Price : $8.95]

FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.

FDA Paper on AI Targets 4 Focus Areas

[ Price : $8.95]

FDA posts a cross-Center paper entitled Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working...

Device Q-Submission Feedback Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Requests for Feedback and Meetings for Medical Device Submi...

Draft Guidance in Device Thermal Effects

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Thermal Effects of Medical Devices That Produ...

Medical Device Regs Technical Amendment

[ Price : $8.95]

Federal Register notice: FDA amends certain medical device regulations to update a citation for information collection and conform...

FDA Guidance on Device Thermal Effects

[ Price : $8.95]

FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation ...

Updated Draft Q-Submission Guidance

[ Price : $8.95]

FDA publishes for comment an updated draft guidance on requesting feedback and meetings with FDA on medical device submissions.

Comments on Advanced Mfg. Tech Guide

[ Price : $8.95]

Four stakeholders suggest ways for FDA to improve its draft guidance on advanced manufacturing technologies designation.

Poseida Orphan Status for CAR-T Cell Therapy

[ Price : $8.95]

FDA grants Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell mem...