On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more
Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more
7/23/2024
/ Chevron Deference ,
Decision-Making Process ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more
5/13/2024
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Section 5
On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more