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Citing deficiencies in the Chemistry, Manufacturing, and Controls (CMC) processes, FDA handed Swiss drugmaker Galderma a complete response letter for RelabotulinumtoxinA, the company’s cosmetic neurotoxin intended to treat frown lines and crow’s feet. Read More
CBER has issued warning letters to manufacturers for product sterility, failure to seek approval for drug and/or biologic products, inadequate labeling and GMP violations. Read More
Eli Lilly announced on Monday that it has received its second FDA complete response letter (CRL) related to findings from an inspection of the third-party contract manufacturing organization, this time for production of the company’s eczema drug, Lebrikizumab. Read More
Only about half of drug manufacturers have systems that comply with what regulatory bodies want to see in Quality Risk Management (QRM) — though the FDA and the International Council for Harmonisation (ICH) both released updated guidance on the topic earlier this year, said Beth Slater, industry veteran and founder and president of consulting firm Quality Confidential. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
A government shut down as of midnight on Saturday — the end of the fiscal year — appears likely as partisan disagreements about federal discretionary spending rage on with no clear end in sight. Read More
Boehringer Ingelheim (BI) has filed a motion for summary judgment in its case against HHS objecting to the Inflation Reduction Act’s (IRA) drug price negotiation program, claiming that the undisputed material facts entitle BI to judgment as a matter of law. Read More
Recommendations on labeling of injectable prescription drug product information submitted in an NDA or certain BLAs is the subject of an FDA guidance on dose banding. Read More
Over the past week, the FDA issued final guidance on quality system considerations and content of premarket submissions for cybersecurity in medical devices. Draft guidances were issued on updating breakpoints in labeling antimicrobial susceptibility test system devices, an electronic submission template for De Novo medical device requests, and developing drugs and biologics for graft-versus-host diseases. Read More