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A federal appeals court on Friday ruled a Native American tribe cannot assert sovereign immunity against inter partesreviews by the U.S. Patent and Trademark Office, in the latest ruling in a battle over Allergan’s dry-eye drug. Read More
Sponsors studying genetic metabolic disorders should put patients on strict diets even before clinical trials start, the FDA says in a draft guidance issued Monday. Read More
The FDA announced on Monday that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Read More
The pharmacy benefit manager group believes the rule will target anti-kickback and Medicare Part D statutes and the protection of pharmaceutical company rebates. Read More
The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how drug prices are formulated. Read More
The FDA released new ICH guidelines designed to help researchers navigate the sometimes conflicting regional requirements and differences in global clinical trials. Read More
The FDA on Friday published 26 new product-specific draft guidances for generic drug trials and 17 revisions, saying it hopes to broaden access and help cheaper drugs get to market more quickly — including opioids formulated to deter abuse. Read More
“The policy and regulatory decisions that we make today are going to have a lot to do with whether we realize the promise for this new category of products,” Gottlieb said. Read More
Gottlieb stressed that the agency is “not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription.” Read More
The Office of New Drugs will gain an Office of Therapeutic Biologics and Biosimilars to bolster reviews of biosimilars and interchangeable products as well as biologics. Read More
Gottlieb said a working group will study how the agency would deem an access issue serious enough to require importation and ways to ensure safety and quality of imported drugs. Read More