Defender SD Manufacturing Hit for Systems Lapses
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…
Teva Gets Form 483 for Unknown Residues, Quality Lapses
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. Source: Drug…
Omega Packaging Hit With Form 483 for Inadequate Test Methods, Other Lapses
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…
FDA Requires Opioids Producers to Supply Mail-Back Envelopes for Disposal
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…
Sartorius to Extend Its Gene Therapy Vector Portfolio in $2.6B Polyplus Purchase
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 Gains De Novo Authorization for Wearable Opioid Overdose Monitor
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…
<i>FDAnews</i> Introduces New Editorial Advisory Board
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…
Sterility Issues Still Plague Eye Care Drugmaker in the Wake of Two Recalls
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…
Jury Says Sandoz Owes $39M for Eyelash Drug Patent Infringement
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 to Appeal FTC’s Order to Divest Liquid Biopsy Maker Grail
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…
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