Drugs

Latest Federal Register Notices

Guidance on Medical Device Development Tools
Federal Register notice: FDA announces the availability of a guidance on “Qualification of Medical Device Development Tools (MDDT)” that is intended to finalize the MDDT program. 08/10/2017

Guide on Expiry Dating for Unit Dose Repackaging
Federal Register notice: FDA announces the availability of a revised draft guidance on “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” 08/09/2017

FDA Guide on CMC Postapproval Changes for BLAs
Federal Register notice: FDA makes available a draft guidance on “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” 08/09/2017

Comments Sought on Biologic Manufacturing Arrangements
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” 08/08/2017

Comments Sought on Drug Ad Information Requirements
Federal Register notice: FDA seeks comments on an information collection for “Prescription Drug Advertisements.” 08/08/2017

48 ANDA Bioequivalence Guidances Published
Federal Register notice: FDA announces the availability of 48 final product-specific guidances that recommend the design of bioequivalence studies to support ANDAs. 08/07/2017

Oncologic Drugs Panel to Review Sutent sNDA
Federal Register notice: FDA announces a 9/19 Oncologic Drugs Advisory Committee meeting to review a C.P. Pharmaceuticals supplemental NDA for Sutent. 08/07/2017

Vaccines Panel to Review Glaxo Zoster Vaccine
Federal Register notice: FDA announces a 9/13 Vaccines and Related Biological Products Advisory Committee meeting that will review GlaxoSmithKline Biologicals’ zoster vaccine recombinant. 08/07/2017

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