The Week9d
WHO Prequalification - exploring opportunities and challenges to Indian IVD manufacturers
Mitigating diseases which have significant societal impact starts with an early and accurate diagnosis. Ensuring access to safe, appropriate and ...
Food Safety News28d
Government Accountability Office finds problems with FDA inspection rates
In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities is understaffing. The Food and Drug ...
Yahoo Finance21d
FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
Dublin, Jan. 30, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day ...
The Hindu22d
Aurobindo Pharma shares decline after U.S. FDA inspection report to subsidiary’s API plant
The U.S. FDA inspection of Unit-2, the API manufacturing facility of Apitoria Pharma in Jinnaram Mandal, Sanga Reddy district, conducted from September 23-27, had concluded with the regulator ...
Food Safety News10d
FDA warns two companies over foreign supplier verification violations
Minnesota-based Talla Imports LLC received a warning letter on Jan. 13, 2025, after FDA inspections conducted from Nov. 20 to Dec. 16, 2024, found the company had not developed or maintained an ...
The Hindu28d
Laurus Labs arm gets one U.S. FDA observation after post-marketing adverse drug experience inspection
A U.S. subsidiary of generic drugmaker Laurus Labs has been issued a Form 483 with one observation by the U.S. Food and Drug Administration (U.S. FDA) after a post-marketing adverse drug ...
Acsh.org23d
FDA’s Failures in the Infant Formula Debacle Cry Out for Reform
Inefficiencies in the FDA’s inspection procedures further compounded the issue. During a subsequent inspection at Abbott’s Sturgis facility in September 2021, a new consumer complaint related to a ...
The National Law Review10d
Proposed FDA Rule May Require Stricter Testing for Talc in Cosmetic Products
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...
abc7NY17d
Chocolate products recalled due to undeclared allergen, more FDA info
The recall was initiated last year after an FDA inspection of the company's facility "where it was discovered that products containing milk, soy, wheat, sesame, FD&C #6 and almonds were ...
CNN9d
FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
Due to concerns about these chemicals’ links to cancer risks, the FDA under the Biden administration considered proposing a ban on these ingredients in certain cosmetic products such as chemical ...
UPI16d
FDA OKs clinical trials for pig kidney transplants in people
The U.S. Food and Drug Administration has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species ...
Popular Science29d
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD ...