To reflect the more current organizational structure and processes in its Office of Generic Drugs (OGD), the FDA has published a manual of policies and procedures (MAPPs) update focused on…
GSK has crossed the finish line with Arexvy (RSVPreF3-AS01E), the first respiratory syncytial virus (RSV) vaccine to win FDA approval for individuals age 60 years and older, but approval of…
Lupin has been hit with a 10-observation Form 483 following an inspection of its Madhya Pradesh, India, drug manufacturing facility that revealed a failure to adequately handle out-of-specification results of…
The FDA has sent Champaklal Maganlal Homeo Pharmacy, located in Gujarat, India, a warning letter citing contamination issues after the agency’s Nov. 15, 2022, request for product testing records. Source:…
The FDA handed APS Pharmacy a warning letter following the company’s response to a Form 483 that failed to address observations of the company’s compounding drug products using ineligible bulk…
The FDA has issued a warning letter to Omega Packaging Corp. for failure to test active pharmaceutical ingredients for impurities and a lack of response from the company to this…
The number of priority review generics applications awaiting FDA action dropped by 25 percent in the first half of fiscal year 2023, signaling that the agency has improved review efficiency,…
Devicemakers and equipment servicing companies are locked in a battle over the idea of “right to repair,” debating whether third-party repair companies should be federally regulated in the same way…
The FDA has adopted the International Council for Harmonization’s (ICH) revised guideline for quality risk management, releasing it in the form of a final agency guidance that advises pharma companies…
Vanda Pharmaceuticals is suing the FDA, charging that the agency illegally revealed proprietary manufacturing information to companies seeking approval for generic forms of two of Vanda’s patented drugs. Source: Drug…