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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
Since the FDA knew the end of the public health emergency was nigh, the agency already had begun working with holders of EUAs to transition them to full approval, Marks said.
An appeals court ruled that Teva “induced infringement” of GSK’s patent by pressing doctors to prescribe its generic version of a cardiac medicine rather than GSK’s brand-name congestive heart failure drug. Read More
The company filed a Freedom of Information Act (FOIA) request asking the FDA to release all of the documents pertaining to its no-go decision. Read More