The FDA yesterday released final guidance for drug manufacturers, packers and distributors on submitting promotional materials in both electronic and nonelectronic formats. Source: Drug Industry Daily

Vanda Pharmaceuticals is suing the FDA, claiming the agency refuses to disclose why it won’t approve the company’s sleep disorder drug Hetlioz (tasimeleton) for jet lag. Source: Drug Industry Daily

The European Medicines Agency’s (EMA) safety committee said it found no evidence for a causal link between the Pfizer/BioNTech and Moderna COVID-19 vaccines and very rare cases of autoimmune hepatitis…

The European Medicines Agency (EMA) has issued draft guidance on redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS). Source: Drug…

Dropping from a high of 47 requests for Regenerative Medicine Advanced Therapy (RMAT) designations in 2018, the FDA has received, so far, just 14 requests this year, according to new…

Claims by CofixRX for its iodine-containing nasal spray render it an unapproved new drug that is misbranded and adulterated, the FDA said, in a warning letter to the company in…

Last week’s Aduhelm coverage decision by the Centers for Medicare and Medicaid Services (CMS) raises the bar for three other antiamyloid antibodies in late-stage development: Eisai’s and Biogen’s lecanemab, Eli…

Bipartisan lawmakers in Congress introduced five bills last week meant to shore up the U.S. supply chain and address the rising costs of prescription drugs. Source: Drug Industry Daily

The FDA and Centers or Medicare and Medicaid Services (CMS) took the rare step Friday of issuing a joint statement to clarify their regulatory authorities one day after the CMS…

The FDA is proposing a rating system to assess drugmakers’ quality management maturity (QMM) as a way to protect against drug shortages and bolster the U.S. supply chain. Source: Drug…