President Donald Trump signed an Executive Order (EO) on Thursday, August 6, 2020 directing federal agencies to “Buy American” when purchasing “essential” drugs, medical supplies and equipment rather than purchase these...more
8/7/2020
/ Buy American Act ,
Environmental Protection Agency (EPA) ,
Essential Goods ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Equipment ,
Medical Supplies ,
OMB ,
Prescription Drugs ,
Trump Administration ,
United States
On December 18, 2019, in a reversal of historic and substantive reservations, the U.S. Food and Drug Administration (FDA or Agency) issued a notice of proposed rulemaking (Proposed Rule) that, if finalized, would allow for...more
On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more
5/14/2019
/ Acquisitions ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Lanham Act ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Wholesale
On October 15, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule requiring disclosures by pharmaceutical manufacturers of the list price for certain drugs and biologicals directly or...more
The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more
The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding...more