(imiglucerase for injection) in May 1994, Genzyme has maintained a worldwide post-marketing database of spontaneously reported adverse events and adverse events discussed in the …
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
Jan 29, 2025 · The FDA cites contamination at Massachusetts plant where Sanofi makes ingredients used to produce various medicines. HealthDay News — The U.S. Food and Drug …
Please refer to your supplemental biologics license application (sBLA), dated and received July 3, 2023, and your amendments, submitted under section 351(a) of the Public Health Service Act …
All promotional materials that include representations about your drug product must be promptly revised to be consistent with the labeling changes approved in this supplement, including any …
FDA cites contamination concerns in warning to Sanofi MA plant
Jan 22, 2025 · Issued on January 15, the Warning Letter followed a US Food and Drug Administration (FDA) inspection at the facility – located 30 km west of Boston, Massachusetts …
Genzyme - Wikipedia
Genzyme focuses on six areas of medicine relating to lysosomal storage diseases, renal disease, orthopedics, transplant and immune diseases, oncology, genetics, and diagnostics. The first …
Thymoglobulin | FDA - U.S. Food and Drug Administration
Oct 1, 2024 · Manufacturer: Genzyme Corporation Indication: For the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. Use in conjunction with concomitant …
How a 15-year-old Genzyme drug shortage became a legal
Feb 26, 2024 · Genzyme eventually agreed to a $175 million fine and an FDA consent decree to resolve the manufacturing woes. Genzyme attempted to mitigate the Fabrazyme shortage with …
Genzyme Corp. Signs Consent Decree to Correct ... - Fierce Pharma
May 25, 2010 · Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal …
May 9, 2020 · Warning letter to Genzyme Corporation, Cambridge, Massachusetts, based on significant objectionable conditions observed during an inspection of
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