JD Supra

FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...

Qalitex Laboratories Offers GMP Consulting for 21 CFR Part 111 Quality System Development

GMP Consulting Supports FDA Audits, SOPs, Testing, and GMP Readiness for Supplement Manufacturers IRVINE, CA, UNITED ...
PharmTech

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and quality leaders: if evidence is increasingly remote-ready and ...
JD Supra

FDA Issues First-of-Its Kind Guidance on Expectations for Drug Manufacturing 483 Responses

Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...
Business Wire

Medical Devices Post Market Surveillance and Complaint Handling Systems Course: U.S. FDA CGMP Expectations/Requirements (ONLINE EVENT/ON-DEMAND) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...
Nasdaq

Plus Therapeutics Announces Summary of FDA Meeting on Company’s cGMP Manufacturing Process for Lead Drug Candidate

cGMP production of 186RNL targeted radiotherapeutic beginning in second half of 2022 to support ongoing and future ReSPECT™ clinical trials The FDA indicated agreement with the Company’s proposed ...

FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
Business Wire

Virtual Course: Developing Effective Medical Devices Post Market Surveillance and Complaint Handling Systems Under Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" training has been added to ...
Morningstar

Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform

SINGAPORE, Jan. 5, 2026 /PRNewswire/ -- Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical's ...