Drugs

Compounded Drug Access Bill Introduced

Rep. Morgan Griffith (R-VA) has introduced the Preserving Patient Access to Compounded Medications Act of 2017 (H.R. 2871), that supporters say will improve access to compounded medicines. The measure addresses office-use compounding when authorized by state law and United States Pharmacopeia or National Formulary monograph requirements. It was referred to the House Energy and Commerce Committee.

Support for the bill was voiced by the National Community Pharmacists Association. The group said in a statement that when the Drug Quality and Security Act became law in 2013, they and other coalition partners turned attention to the implementation process. “During the ensuing years, it has become apparent that a congressional fix was in order to better align the statute, congressional intent, public safety, and patient access to compounded medications,” the group says. “This common-sense bipartisan legislative fix should be supported in the House of Representatives and a companion bill should be introduced in the Senate.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome