Archive for March 2021
FDA’s Device Center Has COVID Test Regrets
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Source: The GMP Letter
Read MoreFDA Appoints Kevin Fu As First Medical Device Cybersecurity Chief
The FDA has named Kevin Fu as acting director of medical device cybersecurity within the Center for Devices and Radiological Health (CDRH) — a newly created position in response to the agency’s growing concerns about cybersecurity threats. Source: The GMP Letter
Read MoreNew Postmarket Surveillance Tool for COVID-19 Vaccines
Health officials are using new tools to gather postmarket safety data on COVID-19 vaccines, including a new early warning system called V-Safe. Source: The GMP Letter
Read MoreEC Agrees on Common List of COVID-19 Rapid Antigen Tests
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Source: The GMP Letter
Read MoreNew Postmarket Surveillance Tool for COVID-19 Vaccines Being Used
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Source: Drug GMP Report
Read MoreFDA Preparing Guidance on Compounding Pandemic Drugs
The FDA announced that it is developing guidance on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.” Source: Drug GMP Report
Read MoreFDA Drug Recalls Rise in 2020, New Report Says
Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Source: Drug GMP Report
Read MoreCDER Outlines its Drug Safety Priorities During the Pandemic
Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks, according to its latest annual report on Drug Safety Priorities. Source: Drug GMP Report
Read MoreAlembic Pharmaceuticals Draws Form 483 Over Five Quality Observations
Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Source: Drug GMP Report
Read MoreVaccine Developers Face Challenges in Scaling Up Manufacturing
A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations. Source: Drug GMP Report
Read More