CFPB's Policy Statement on Abusiveness (Part 2) - The Consumer Finance Podcast
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more
Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more
In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more
In Washington: The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday. If the Food and...more
On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more
This memorandum summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA has issued a temporary policy to provide flexibility to chain restaurants and...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
USDOT safety-sensitive employees cannot use cannabidiol ("CBD") products without impunity. On February 18, 2020, the U.S. Department of Transportation’s Office of Drug and Alcohol Policy and Compliance (“USDOT”) issued a...more
Seyfarth Synopsis: CBD is “thriving” in the current regulatory environment, but is it doing so illegally? As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week, “the CBD craze is...more
On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more
The Food and Drug Administration (FDA) issued its 2018 Strategic Policy Roadmap (the Policy Roadmap) in an effort to provide the public with insight into select key priorities of the FDA for 2018. While the document is not...more
The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar...more