Regulatory Affairs

Pacira Cites Amarin in Off-Label Claim Against FDA

Citing a recent federal court ruling that truthful off-label claims are protected free speech, Pacira Pharmaceuticals has sued the FDA, claiming a First Amendment right to promote its Exparel postsurgical non-opioid analgesic for unproven uses. Read More

NHS England Plans to Pull 16 Cancer Drugs from Fund

NHS England will no longer pay for 16 cancer drugs, including products made by Roche, Celgene, Pfizer, Bristol-Myers Squibb, Novartis, Johnson & Johnson and Bayer, after the National Institute for Health and Care Excellence deemed them not cost-effective. Read More

Viral Shedding Studies Focus of U.S. FDA Final Guidance

Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the U.S. Food and Drug Administration says. Read More