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In a move to help prevent or mitigate shortages, the FDA is asking drugmakers to provide more information regarding manufacturing disruptions that could affect finished drugs and biological products as well as some active pharmaceutical ingredients (API). Read More
AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing that the errors were due to complex and sometimes conflicting regulations. Read More
The FDA rapped Omega Packaging Corp with a nine-observation Form 483 following an inspection of its Totowa, N.J., facility for deficient test methods and other lapses in its manufacture of hand sanitizers. Read More
Teva Pharmaceuticals was given a three-observation Form 483 following an inspection of its Fairfield, N.J., finished product manufacturing firm for inadequately cleaned and maintained equipment and other lapses. Read More
The FDA handed Defender SD Manufacturing a five-observation Form 483 following an inspection of its San Diego, Calif., facility for a quality unit that lacked authority to investigate errors, lack of written production procedures and environmental monitoring deficiencies, among other lapses. Read More
The FDA handed Advanced Accelerator Applications a five-observation Form 483 after conducting an inspection of its Millburn, N.J., facility for failure to establish written procedures for production and process controls for its drug products, and other lapses. Read More
In its latest move to address the opioid overdose crisis, the FDA is requiring opioid manufacturers to provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers to make it easier for patients to dispose of unused opioids. Read More
In a move to expand its offerings for cell and gene therapy developers, German biotech Sartorius has announced plans to purchase Polyplus for $2.6 billion, gaining access to the Strasbourg, France-based company’s viral vector production technology. Read More
FDAnews welcomes to its new editorial advisory board seven thought leaders with deep experience in the drug, device and clinical research industries. These seven experts are at the top of their field and will help provide our readers with even greater depth and analysis of drug and device industry news and trends. Read More