Drugs

Latest Federal Register Notices

FDA Withdraws Haemonetics ANDA
Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags. 11/08/2019

Info Collection on Generic Drug Correspondence
Federal Register notice: FDA submits to OMB an information collection revision entitled for “Controlled Correspondence Related to Generic Drug Development OMB Control No. 0910-0797." 11/08/2019

Comments Sought on Post-market Surveillance Practices
Federal Register notice: FDA seeks comments on a draft document that details best practices for drug safety surveillance. 11/07/2019

8 FDA Info Collections Gain OMB Approval
Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB. 11/06/2019

Allergenic Products Advisory Committee Needs Rep
Federal Register notice: FDA seeks industry organizations to participate in selecting nonvoting industry representative to serve on CBER’s Allergenic Products Advisory Committee. 11/05/2019

Hep D Virus Drug Development Guide
Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” 11/01/2019

Draft Guide on Generic Drug User Fees
Federal Register notice: FDA makes available a draft guidance entitled “Assessing User Fees under the Generic Drug User Fee Amendments of 2017.” 11/01/2019

Panel to Review Correvio Atrial Fibrillation Drug
Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Correvio International NDA for its atrial fibrillation drug. 11/01/2019

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

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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