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. Source: Drug Industry Daily

Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo…

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…

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…

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

Citing a continued dramatic growth in the use of laboratory-developed tests (LDT) over the past two decades, the FDA Friday announced a proposed rule that would bring the tests under…

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…

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…

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. Source: Drug Industry Daily

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…