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Industry News

FDA Clears Up Labeling Situation for Sprout Pharma’s Female Libido Drug

September 20, 2019
The FDA asked Sprout to withdraw the press release and reached out to media outlets to explain that the changes have not yet been cleared. Read More

Advisory Committee Supports Aimmune’s Peanut Allergy Drug

September 20, 2019
Results of a phase 3 clinical trial which showed that 67 percent of patients treated with the therapy could tolerate up to 600 milligrams of peanut protein with no more than mild to moderate symptoms. Read More

GSK’s Eosinophilic Asthma Biologic Approved by FDA for Children

September 20, 2019
Nucala first received the agency’s approval in 2015 as an add on maintenance treatment for severe eosinophilic asthma patients.  Read More

FDA’s Top Ten GMP Inspection Findings for FY 2019

September 19, 2019
With less than two weeks to go in fiscal 2019, an FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles. Read More

DA Raps Ipca Laboratories’ Quality Unit for ‘Cascade of Failure’

September 19, 2019
The company also left multiple complaint investigations open for long periods. Read More

San Diego Manufacturer Cited for Equipment Design

September 19, 2019
An ISO 5 operator continuously moved falling filled, capped and crimped product vials to keep them standing. Read More

Costa Rican OTC Drugmaker Hit for Testing, Stability Program

September 19, 2019
The company said it would employ a third-party testing laboratory, but it didn’t provide a description of the test it would conduct. Read More

Spanish Sterile Drugmaker Cited for Quality Lapses

September 17, 2019
The FDA hit Laboratorio Reig Jofre for numerous violations at its Barcelona sterile drug manufacturing facility, including inadequate smoke studies and failing to qualify contract service providers. Read More

FDA Warns South Korean Drugmaker for Multiple CGMP Failures

September 16, 2019

South Korean OTC drug manufacturer Enprani drew a warning letter from the FDA for CGMP violations observed by FDA investigators at its Incheon facility — including the release of products for sale in the U.S. without checking the identity and strength of their active ingredients. Read More
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