Articles and Blogs

On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how... READ MORE

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The first was a Warning Letter issued on August 4, 2023, to a pharmaceutical manufacturer for... READ MORE

On August 16, 2023, a three-judge panel of the Fifth Circuit Court of Appeals issued an opinion in the ongoing litigation regarding the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a... READ MORE

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome. Specifically, OPDP alleged that a website promoting the... READ MORE

On June 6, 2023, the U.S. Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. The Draft Guidance, which is aimed at enabling the incorporation of rapidly evolving technological and methodological innovations into clinical trials, is adapted from the International... READ MORE

On January 3, 2023, the U.S. Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”). The updated Mifepristone... READ MORE

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). The proposed regulation is issued pursuant to requirements for national regulatory standards under the Drug Supply Chain Security Act (“DSCSA”), which is part... READ MORE

In The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration, the U.S. Court of Appeals for the D.C. Circuit overturned a 2020 Food and Drug Administration (“FDA”) rule banning the use of electrical stimulation devices to treat patients suffering from severe self-injurious and aggressive behaviors. The court concluded the FDA... READ MORE

Thursday, June 18 Update Note – ​ Our Federal Advocacy Team is dedicated to providing frequent COVID-19 updates as they develop. We believe this is the most up-to-date information available at this time. These updates along with other resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website​. To learn more about... READ MORE

Tuesday, June 9 Update Our Federal Advocacy Team is dedicated to providing frequent COVID-19 updates as they develop. Going forward, these updates will be distributed as developments warrant instead of nightly. These updates along with other resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website​. Note – ​we believe this is... READ MORE