In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more
1/13/2023
/ Abortion ,
Biden Administration ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Policy Statement ,
Pregnancy ,
Reproductive Healthcare Issues ,
State and Local Government
In a historic presidential election that began during the COVID-19 pandemic and ended with record voter turnout and mail-in ballots, former Vice President Joseph Biden of Delaware was declared the 46th president of the United...more
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 June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
On May 11, the U.S. Food and Drug Administration (FDA) released two guidance documents to provide recommendations for sponsors “to accelerate development” of drugs and biologics designed to prevent or treat COVID-19. ...more
On Friday, April 10, 2020, the Food and Drug Administration (FDA) announced that it has issued two additional Emergency Use Authorizations (EUA) in response to the coronavirus pandemic: one for a device that is used to...more
On April 1, 2020, FDA issued a guidance document instructing companies on how to notify the agency of a permanent discontinuance or interruption of manufacturing of certain products pursuant to Section 506C of the FDCA (21...more
4/9/2020
/ Advertising ,
Class Action ,
Coca Cola ,
False Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Lanham Act ,
NLEA ,
POM Wonderful ,
POM Wonderful v Coca Cola ,
SCOTUS
In response to the public health threat of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has formed a special emergency program to expedite development of COVID-19 therapies – the Coronavirus Treatment...more
The U.S. Food and Drug Administration (FDA) announced in a March 27, 2020 letter to industry that the Center for Biologics Evaluation and Research (CBER) has implemented new measures to prioritize biological product...more
On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more
In response to the COVID-19 pandemic, and in light of the persistent shortage of diagnostic tests for the SARS-CoV-2 virus, the U.S. Food and Drug Administration (FDA) provided recent but overdue guidance on the use of its...more
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
Introduction -
Congress enacted the Medical Device Amendments in 1976 establishing the regulatory framework for evaluating safety and effectiveness of medical devices. The U.S. Food and Drug Administration (“FDA” or...more
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
On September 28, 2018 the U.S. Food and Drug Administration (FDA or Agency) issued two draft guidance documents focusing on clinical trial designs to advance drug development and competition. Both documents aim to streamline...more
On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more
On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more
On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...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