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FDA General

Latest Federal Register Notices

FDA Webview posts the Federal Register notices for the week ending 6/7/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 6/7/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Medical Devices

Innovative Healths IBS Nerve Stimulator Cleared

FDA clears an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal ...

Federal Register

Workshop on Generating Real-World Evidence

Federal Register notice: FDA announces a 7/12 public workshop entitled Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regul...

Federal Register

Nonalcoholic Steatohepatitis Drug Development Guide

Federal Register notice: FDA makes available a draft guidance entitled Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for T...

Federal Register

Draft Guide on Enhancing Trial Diversity

Federal Register notice: FDA makes available a draft guidance entitled Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, En...

Medical Devices

Ex-Advanced BioHealing CEO Settles Marketing Suit

Former Advanced BioHealing chairman and CEO Kevin Rakin pays the government $2.5 million to settle False Claims Act allegations that he knowingly allo...

Human Drugs

FDA Hits Pharmasol with Warning Letter on GMPs

FDA releases a 3/14 Warning Letter to Pharmasol after conducting two 8/2018 facility inspections at South Easton, MA and Stoughton, MA, and citing sig...

Human Drugs

2 New Nucala Administration Options Approved

FDA approves two new methods for administering GlaxoSmithKlines Nucala (mepolizumab) an autoinjector and a pre-filled safety syringe for patients wi...