Drugs

FDA Issues HIV Drug Development Guidances

FDA has issued two final guidances to help product sponsors understand agency thinking about preventive treatments for HIV as well as treatments for pediatric patients with HIV. The first guidance, Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis, gives sponsors nonclinical and clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products, including small molecules and monoclonal antibodies, regulated within CDER for preventing sexually acquired HIV-1 infection. The document addresses agency thinking on the overall development program and clinical trial designs to support development of systemic drug products for preventing HIV-1 infection. It does not address development of vaginal microbicide drug products.

The second document, Pediatric HIV Infection: Drug Product Development for Treatment, provides general recommendations on developing antiretroviral drug products for treating HIV infection in pediatric patients. It is to help sponsors understand when it is appropriate to initiate pediatric formulation development and begin pediatric studies.

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