News and Updates by the Food and Drugs Administration (FDA)
Philips (NYSE: PHG) announced today it has reinforced its strategic alliance with Sim&Cure. Known for their cutting-edge digital approaches in neurovascular therapies, Sim&Cure initially partnered with Philips, which is based in Amsterdam, five years ago. Now, they are embarking on […]
Philips Extends Alliance with Sim&Cure to Boost Neurovascular Treatment Read More »
Johnson & Johnson MedTech has announced an important milestone: the FDA has extended approval for use of Impella heart pumps in treating certain pediatric patients. The approval expansion includes the use of the Impella 5.5 with SmartAssist and the Impella
FDA Expands Approval of Impella Heart Pumps for Pediatric Use Read More »
Bausch + Lomb announced today that it has begun considering the possibility of a sale following a request from regulatory authorities. The eye care company, headquartered in Vaughan, Ontario, was prompted by the Canadian Investment Regulatory Organization (CIRO) due to
Bausch + Lomb Considers Prospective Sale Read More »
Date Listed Date of Letter Name of Company Issuing Department Topic 11/05/2024 06/03/2024 Top Health Manufacturing, LLC Division of Human and Animal Food Operations West IV CGMP/Dietary Supplement/Adulterated 11/05/2024 10/10/2024 Analytical Food Laboratories, Inc. Center for Drug Evaluation and Research
Recent USFDA Warning Letters Released for November 2024 Read More »
Date Released Date of Issue Business Name Office of Issue Topic 10/01/2024 08/13/2024 NRS Enterprises, Inc. d/b/a Sunflour Bakery Division of Human and Animal Food Operations West V CGMP/Food/Prepared, Packed or Held Under Unsanitary Conditions/Adulterated 10/01/2024 09/20/2024 Shake Hemp Center
Recent USFDA Warning Notices Released for October 2024 Read More »
Date Posted Date Issued Organization Issuing Division Category 09/03/2024 08/19/2024 Kaylaan LLC Division of Pharmaceutical Quality Operations I CGMP/Adulterated Pharmaceuticals 09/03/2024 08/16/2024 EBCREATE Store Center for Tobacco Products Tobacco Act/Misbranded 09/03/2024 08/01/2024 Dasada Group LLC Division of Southwest Imports FSVP
USFDA Releases September 2024 Warning Letters Read More »
Issued On Dated Company Department Focus Area 08/06/2024 07/23/2024 Omega Tech Labs LLC Pharmaceutical Quality Operations Dept. IV CGMP/Finished Drugs/Adulterated/Unapproved 08/06/2024 08/01/2024 Guangzhou Baiyunshan Pharmaceutical CDER CGMP/Finished Drugs/Adulterated 08/06/2024 07/17/2024 Velocity Pharma LLC CDER CGMP/Finished Drugs/Adulterated 08/06/2024 07/16/2024 La Parcela
Recent Release of August 2024 USFDA Compliance Notices Read More »
ICICI Prudential Life Insurance recently unveiled ICICI Pru Wish, a groundbreaking health insurance product focused on women-specific serious ailments and surgeries. Created in collaboration with the Reinsurance Group of America (RGA), this insurance scheme targets the distinct health issues faced
DigiNerve, an innovative educational technology initiative by Jaypee Brothers Medical Publishers, is setting a new standard in orthopaedic medical instruction through the launch of its all-encompassing MS orthopaedics program. This course, crafted under the mentorship of top orthopaedic surgeons and
Introduction to Lasix ONYU’s Tentative Approval Gerresheimer, a pioneering provider of systems and solutions across pharmaceutical, biotech, and cosmetic sectors, announces the US Food and Drug Administration’s (FDA) provisional approval of SQ Innovation’s Lasix ONYU. This combination product, designed for