FDA Policy/General

Latest Federal Register Notices

Workshop on Human Skin Safety Testing for Topicals
Federal Register notice: FDA announces a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.” 08/10/2018

FDA Proposes New Drug Promotion Study on Disclosures
Federal Register notice: FDA submits to OMB a new information collection study entitled “Disclosures in Professional and Consumer Prescription Drug Promotion” (OMB Control Number 0910-New). 08/10/2018

Guide on Drug Dissolution Testing
Federal Register notice: FDA makes available a guidance entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.” 08/09/2018

Prolixin Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Prolixin (fluphenazine hydrochloride) tablets, 1 mg (mg), 2.5 mg, 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. 08/09/2018

4 NDA Approvals Withdrawn by FDA
Federal Register notice: FDA withdraws approval of four NDAs from multiple applicants after they told the agency that the products were no longer marketed. 08/08/2018

27 ANDAs Being Withdrawn by FDA
Federal Register notice: FDA withdraws 27 ANDAs from multiple applicants after the application holders told the agency that the drug products were no longer marketed. 08/08/2018

Info Collection Extension for Device Reclassification Petitions
Federal Register notice: FDA submits to OMB an information collection extension for “Reclassification Petitions for Medical Devices” (OMB Control Number 0910-0138). 08/07/2018

Draft Guide on Opioid Use Disorder Drug Endpoints
Federal Register notice: FDA makes available a draft guidance entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” 08/07/2018

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