Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter
50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated d
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types
http://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types
FDA Roundup: September 29, 2023
FDA Roundup: September 29, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-29-2023
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
http://www.fda.gov/news-events/press-announcements/fda-launches-pilot-program-help-further-accelerate-development-rare-disease-therapies
FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests
FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests
http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes
FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes
http://www.fda.gov/news-events/press-announcements/fda-seeks-fines-against-22-retailers-selling-illegal-youth-appealing-e-cigarettes
SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance
ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tab
FDA Roundup: September 26, 2023
FDA Roundup: September 26, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-26-2023