In June 2021, we published Cosmetics Companies: Beware of PFAS, highlighting the recently introduced No PFAS In Cosmetics Act and recommending that cosmetics and personal-care product companies examine their products and...more
On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).
Under...more
This past week, the Indiana General Assembly passed, and Governor Eric Holcomb signed, Senate Bill 1 to provide civil tort immunity from claims arising from COVID-19. This immunity includes claims related to premises...more
On January 28, 2021, Norris Cochran, the acting secretary of the U.S. Department of Health and Human Services (HHS), amended the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical...more
On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) amended its Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19 in order to clarify...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
6/22/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Revocation ,
Secretary of HHS
This alert discusses the scope of claims that may be covered under the Public Readiness and Emergency Preparedness Act’s (the PREP Act) immunity provision. If you are a product manufacturer or distributor, government...more
Component part manufacturers of important lifesaving and life-protecting equipment have been essential players in the first line of defense against the COVID-19 pandemic. In the previously normal legal context, these...more
On April 14, 2020, the General Counsel for the Department of Health & Human Services (HHS) issued an Advisory Opinion (the Opinion) concerning the Public Readiness and Emergency Preparedness Act (the PREP Act) and the March...more
The COVID-19 pandemic has called upon manufacturers and distributors of products to develop, supply and administer the protective tools necessary to combat the spread of infectious disease. For companies that wish to...more
The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more
The BPCIA and the Debate Over Naming Biosimilars -
Most drugs on the market today are small-molecule compounds with active pharmaceutical ingredients that can be duplicated to create “generic” drugs. It is impossible,...more
The passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 paved the way for the introduction of biosimilars in the United States. Biosimilars are large-molecule drugs that are highly similar, but not...more