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The FDA has issued a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent with the commitments made in the GDUFA III commitment letter. 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
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
Around the same time AstraZeneca was signing its price negotiation agreement with CMS for its diabetes drug Farxiga, which is included in the Inflation Reduction Act’s (IRA) first list of Medicare Part D high cost drugs, the company was also filing a motion for summary judgment for the courts to declare the IRA unconstitutional. Read More
Royal Philips has denied reports that it withheld evidence of sleep and respiratory ventilator product malfunctions for more than a decade, arguing that recent media articles mischaracterize the Amsterdam-based devicemaker’s safety history. Read More