Trump touts “historic” plan to overhaul Medicare payments, create...
President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare...
View ArticleFDA aims to harmonize its human subject protection regulations with Common Rule
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The guidance...
View Article12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between...
View ArticleFTC takes on deceptive stem cell therapy claims for blindness cure and autism...
On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn...
View ArticleFDA and DoD strengthen collaboration for medical products with military...
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will...
View ArticleFDA introduces new standardized inspection protocols for sterile drug...
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during...
View ArticleFTC backs FDA guidance intended to curtail citizen petition “shenanigans”
On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. This...
View ArticleFDA’s Bendeka decision reverses approvals of Treanda generics
Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court...
View ArticleClik here to view.
FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough...
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to...
View ArticleNew drug marketing applications: how do EMA and FDA compare?
1. Introduction A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration...
View Article
