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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.

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Federal Register notice: FDA makes available a draft guidance entitled Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for T...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Federal Register notice: FDA makes available a draft guidance entitled Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, En...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...

Human Drugs

FTC Moves to eFiling for Brand/Generic Drug Settlements

The Federal Trade Commission implements electronic filing to replace hard-copy submissions involving brand name and generic drug company agreements fo...