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Marketing

Stakeholders Question Disease Awareness Ad Research

Stakeholders question an FDA proposal to conduct research into the relationship between disease awareness and product-specific television ads.

Medical Devices

FDA OKs Medtronic Pipeline Flex Embolization Device

FDA approves a new indication for Medtronics Pipeline Flex embolization device.

Human Drugs

ICH Working on Generic Drug Standards Harmonization

The International Conference on Harmonization outlines roles an informal discussion group on generic drugs will play to explore harmonization of scien...

Medical Devices

FDA Cautions on Breast Implant Risks

FDA updates medical device reports on the risk of breast implant associated-anaplastic large cell lymphoma associated with all forms of breast implant...

Human Drugs

CDER Implementing Drug Regulation Modernization

CDER director Janet Woodcock says the Center will implement a new multidisciplinary team NDA and BLA regulatory approval program in this fiscal year.

Federal Register

Panel to Review Karyopharm Multiple Myeloma Drug

Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting to review a Karyopharm Therapeutics NDA for treating multiple...

Federal Register

Eosinophilic Esophagitis Drug Development Guide

Federal Register notice: FDA makes available a draft guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment.

Human Drugs

FDA Guide on Developing Buprenorphine Depot Products

FDA issues a final guidance entitled Opioid Use Disorder (OUD): Developing Buprenorphine Depot Products for Treatment.

Human Drugs

Draft Guide on Eosinophilic Esophagitis Drug Development

FDA releases a draft guidance entitled: Eosinophilic Esophagitis (EoE): Developing Drugs for Treatment that assists sponsors with their clinical devel...

Federal Register

Generic Drug Regulatory Science Initiatives Workshop

Federal Register notice: FDA announces a 5/1 public workshop entitled FY 2019 Generic Drug Regulatory Science Initiatives.