The Michigan Senate recently passed a bill to repeal a long-standing state law immunizing pharmaceutical manufacturers and sellers from product liability suits where the pharmaceutical products were approved by the U.S. Food...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
10/31/2023
/ Comment Period ,
FDA Approval ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
On January 4, 2022, the White House Office of Science and Technology ("OSTP") released guidance for federal agencies to implement National Security Presidential Memorandum 33 ("NSPM-33"). Issued in the final days of the Trump...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
Applicable manufacturers will need to update their methods of documenting payments and transfers of value to include the newly expanded list of providers.
A bill recently signed into law expands the reporting requirements...more