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While the FDA has a longstanding requirement that risk information must be included in television and radio prescription drug ads, the final rule the FDA just issued focuses on ways to help consumers notice, attend to, and understand the drug’s risks. Read More
The UK government, England’s National Health Service (NHS) and the Association of the British Pharmaceutical Industry (ABPI) have agreed to a drug pricing deal that will save the government £14 billion ($17 billion) over five years, and support research investment. Read More
This edition of Quick Notes highlights a permanent injunction against a manufacturer of dietary supplements, request for improved post-market evidence standards, a study on lessening cyber threats to legacy devices, drug distribution partners going all-electronic and seeking input on pulse oximeter discrepancies. Read More
Companies that make pharmaceutical, biologic and medical devices are caught hiding relevant information or purposefully delaying applying for patents at the U.S. Patent & Trademark Office (USPTO) in gamesmanship moves that occur in the medical field far more than in other industries, according to recent reports. Read More
An Arizona company marketing an unapproved vaginal contraceptive cream has settled a federal complaint and agreed to stop distributing the product until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Read More
The FDA has published 40 new and revised product-specific guidances (PSG) which provide recommendations for developing generic drugs and generating evidence to support ANDA approvals. Read More
A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for patients aged 12 and over. Read More
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more. Read More
IQVIA, the global contract research organization juggernaut, has filed its opposition to the FTC’s proposed preliminary injunction halting its acquisition of Propel Media, the latest in its back and forth with the federal regulator over the latter’s fears surrounding consolidation in the digital healthcare advertising market. Read More