By James R. Phelps – Many seasoned FDA watchers are surprised by the kerfuffle raised when HHS overturned FDA’s plan to allow Plan B emergency contraception available over the counter…

…make PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (“PBOS”) available Over-the-Counter (“OTC”) without age or point-of-sale restrictions upon the aproval of a supplemental New Drug Application (“SNDA”) submitted by the…

…is wholly unclear whether the PAG plan can achieve these objectives. Without a doubt, this portion of the PAG plan seems the least realistic, as it anticipates the removal of…

…apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations)….

…Plan” proposing two pathways to allow for the importation of drugs from foreign countries. Pathway 1 will allow States, wholesalers, and pharmacists to submit plans to HHS for demonstration projects…

…(D-VI) (who is chairwoman of the Congressional Black Caucus Health Braintrust) and expresses the strong support of members of the Congressional Black Caucus for Section 37 of the House-passed version…

…to offer the qualifying product at a “reasonable price” (as defined in the bill) and to publicly disclose all pre-clinical and clinical trial data relating to the product, the award…

By Ricardo Carvajal – The National Nanotechnology Initiative (“NNI”) released its draft 2014 Strategic Plan for comment.  The draft plan lays out the NNI’s goals and objectives, which remain largely…

…health care industry. Medical Devices HHS OIG is planning to review the “Medicare Costs Associated with Defective Medical Devices” as well as “Payment Credits for Replaced Medical Devices That Were…

…strategic plan focused on foodborne illness source attribution. The second plan appears geared to not only improve estimates of attribution, but also “develop methods to estimate how sources [of foodborne…

…other Federal health care programs. (p. 41). (One wonders how the latter federal payors (e.g., the TRICARE retail drug benefit) can be considered “buyers” when Part D plans and MMCOs…

…The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides for civil money penalties and no-tobacco-sale orders for violations of FDCA requirements relating to restrictions on the sale and distribution of…

…filed criminal and civil charges against a company and also sought the forfeiture of violative products against a company. It is also noteworthy that the civil Complaint alleges that Roos…

By James P. Ellison – We previously reported on FDA’s Federal Register notice adjusting its civil penalties for inflation and noted our prior posts on the new civil penalty authority given…

…of global resolution of all potential criminal and civil charges, the end of either a criminal or civil case may not mean the end of a company executive’s legal problems….