The FDA has told Fullerton, Calif.-based Synovo Production to cease manufacture of its hip cup replacement system because the company failed to notify the agency about significant changes to the…
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…
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…
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…
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,…
Masimo’s Opioid Halo system — the first FDA-authorized monitoring solution for detecting opioid-induced respiratory depression — has been granted a De Novo authorization for sale over the counter and by…
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…
Global Pharma Healthcare — the Chennai, India-based drugmaker that has issued two recent high-profile recalls of its eye drops for potential contamination — drew an 11-observation Form 483 from the…
A federal jury has ordered Novartis’ Sandoz subsidiary to pay $39 million in damages to Allergan and Duke University for infringement of patent rights for Allergan’s eyelash-enhancing therapy Latisse (bimatoprost).…
Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple…