Four major industry groups shared their thoughts on the International Council for Harmonization’s E6(R3) draft GCP guidelines, commenting on stakeholder engagement, diversity, service provider evaluations and pointing out areas that…
The FDA recommends that “trading partners” use the Electronic Product Code Information Services (EPCIS) standard — developed by GS1 — for compliance with the Drug Supply Chain Security Act (DSCSA)…
The Patient Engagement Advisory Committee (PEAC) — FDA’s only advisory committee comprised solely of patients, caregivers, and patient advocates — is seeking guidance on improving access to home-use medical devices…
The FDA spells out the process for a generic drug facility to request a meeting to discuss deficiencies outlined in a warning letter, in a draft guidance released Friday. Source:…
After dropping its challenge to the proposed transaction last week, the FTC will allow Amgen’s $27.8 billion buyout of Horizon Therapeutics to proceed under terms set in a consent order…
The FDA’s Center for Drug Evaluation and Research (CDER) seeks to dispel “possible misconceptions” about its proposed quality management maturity (QMM) system in a new white paper. Source: Drug Industry…
Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary…
The FDA has deemed as class I another in a series of voluntary recalls from Getinge/Maquet/Datascope for various models of its Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pump (IABP),…
AdvaMed and the Medical Device Manufacturers Association (MDMA) commented this week on a CMS notice expediting Medicare coverage of emerging technologies, urging swift acceptance of the program, but also arguing…
Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) want the FDA to close loopholes that keep generic drugs off the market, they said in a recent letter to FDA…