Archive for July 2019
Energy and Commerce Committee Seeks Details on FDA’s Stem Cell Enforcement
The clock is ticking on the FDA’s enforcement discretion period for stem cells and other new therapies, and Congress raised concerns and questions with the agency about its plans going forward in a letter last week. Source: Drug Industry Daily
Read MoreFDA OKs Boxed Warning for Pfizer’s Xeljanz Following Serious Safety Concerns
The FDA has approved new warnings for Xeljanz and Xeljanz XR (tofacitinib), including a boxed warning. The warning of an increased risk of blood clots and death applies to the 10 mg twice daily dosage of the drug, which is approved for certain patients with ulcerative colitis. Source: Drug Industry Daily
Read MoreFDA Warns India-based Indoco For Data Integrity Concerns
The FDA hit Indoco Remedies with a warning letter for significant CGMP violations related to data integrity following an inspection of its production facility in Goa, India. Source: Drug Industry Daily
Read MoreSenate Finance Committee’s Bipartisan Drug Pricing Bill Advances
Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.)’s drug pricing package is headed to the Senate floor, following the Senate Finance Committee’s markup and 19-9 approval yesterday. Source: Drug Industry Daily
Read MoreEC Releases New Guidance on Data Exchange Options
After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange. Source: The GMP Letter
Read MorePart 806 Reports — When to Submit Them and How to Avoid Pitfalls
Covington & Burling attorney Pamela Forrest offered insights into when devicemakers must file recall reports with the FDA to comply with 21 CFR Part 806 in a recent FDAnews webinar, flagging areas of confusion and how to avoid common errors. Source: The GMP Letter
Read More483 Roundup: FDA Flags Four Firms for GMPs, Quality
The FDA cited four devicemakers following inspections that revealed problems with process controls, validations, complaint handling and medical devices reports. Source: The GMP Letter
Read MoreDevicemakers Comment on Machine Learning for SaMD
A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device, Philips said in a comment on the agency’s draft framework document. Source: The GMP Letter
Read MoreGS1 Issues New Guidelines That Reflect New UDI Requirements
GS1 released updated guidance to help devicemakers comply with new unique device identifier requirements under the FDA’s updated standards. Source: The GMP Letter
Read MoreMore Notified Bodies Give Up on EU MDR/IVD Certification
The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t be offering certification. Source: The GMP Letter
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