The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
12/20/2023
/ Bayh-Dole Act ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Contractors ,
Federal Trade Commission (FTC) ,
Inflation Reduction Act (IRA) ,
Innovation ,
Intellectual Property Protection ,
Inventions ,
Licenses ,
March-in-Rights ,
National Institute of Health (NIH) ,
NIST ,
Notice of Proposed Rulemaking (NOPR) ,
Orange Book ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Health Emergency ,
Research and Development
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
6/2/2022
/ Animal Testing ,
BsUFA ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
HELP ,
Manufacturers ,
Medical Device User Fee Program (MDUFA IV) ,
PDUFA ,
PFAS ,
Prescription Drugs ,
Public Health ,
Public Health Service Act ,
Purple Book ,
REMS ,
Title III