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With the quality metrics movement resurfacing and CDER’s quality maturity model publication in the news, lately I have been giving much thought to what quality culture means and how to recognize a strong culture of quality in a pharmaceutical facility. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The election of newly installed Speaker of the House Mike Johnson (R-La.) means the impending government shutdown on Nov. 17 almost certainly won’t occur, says Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More
Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities. Read More
A new publicly searchable database contains detailed information on all 141 Alzheimer’s disease (AD)-targeting drugs involved in 187 active clinical trials in the U.S. and around the world. Read More
Sen. Bernie Sanders (I-Vt.) sent a letter to the HHS Inspector General seeking investigation into an NIH proposal granting an exclusive patent license to an “obscure company linked to a former employee” for a treatment for cervical cancer. Read More
The FDA has issued a warning letter to Illinois drugmaker Abbott Laboratories regarding its Similac Probiotic Tri-Blend for infants, over marketing claims that render the product an unapproved new drug and unlicensed biological product, and followed up with a general notice of its concerns about the use of probiotics on preterm infants on Thursday. Read More
Oncologists were more likely to provide low-value cancer care drugs after receiving money from the pharmaceutical companies that make those drugs, raising questions about the harm caused to patients by the drug industry, according to a new study published in The BMJ. Read More
The FDA’s guidance on developing topical corticosteroids provides ANDA applicants with recommendations on pilot and pivotal studies to assess bioequivalence of the drugs. Read More
In this edition of Quick Notes, we cover a Philips study confirming the safety of its cardiac diagnostic device, FTC action against deceptive marketing of a COVID-19 protection device, and updates to two FDA medical device event reporting databases. Read More