Australia Hikes GMP Clearance Fees
Drugmakers in Australia will soon be subject to higher GMP clearance fees, the Therapeutic Goods Administration (TGA) announced Wednesday. Source: Drug Industry Daily
CHMP Gives Thumbs Down to Sickle Cell Treatment
A key committee is urging European regulators to turn down a sickle cell treatment—two years after their American counterparts approved the drug. Source: Drug Industry Daily
Novartis’ Wonder Drug Comes at Wondrous Price
The price tag for Novartis’ newly approved and seemingly miraculous gene therapy for a rare childhood disease presents a whole new challenge of its own. Source: Drug Industry Daily
FDA Hits Texas Drug Facility for Oversight of Pilot/Exhibit Batches
The FDA cited Sovereign Pharmaceuticals for quality and other failures observed during a Dec. 11-19 inspection of its facility in Fort Worth, Texas—including its failure to ensure the quality of…
Gottlieb Features Compounding in Farewell Congressional Testimony
Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators on April 3. Source: Drug GMP Report
European Parliament Evens Scales for Generics Makers With New Waivers
European drugmakers will be allowed to make generics and biosimilars after the European Parliament voted in favor of manufacturing waivers that will allow their export. Source: Drug GMP Report
483 Roundup: Four Drugmakers Cited Over Quality Problems
Four U.S. drug manufacturers were handed Form 483s for quality violations observed at their facilities, such as issues with quality monitoring, facility maintenance and unqualified handling of quality responsibilities. Source:…
Warning Letter Roundup: Four Companies Hit for GMP Violations
The FDA issued warning letters to four drugmakers for various GMP violations at their facilities, including quality unit shortcomings. Source: Drug GMP Report
FDA Issues Draft Guidance for Handling Recalls
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Source: Drug…
FDA Urged to Clarify Voluntary Quality Standards for Combination Products
A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Source: Drug GMP Report
- Go to the previous page
- 1
- …
- 50
- 51
- 52
- 53
- 54
- 55
- 56
- …
- 610
- Go to the next page