The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
12/11/2024
/ Acquisitions ,
Affordable Care Act ,
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Canada ,
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Trump Administration ,
United States-Mexico-Canada Agreement (USMCA) ,
Universities ,
Waivers
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
1/10/2023
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BsUFA ,
Clinical Trials ,
Cosmetics ,
Disclosure Requirements ,
Diversity and Inclusion Standards (D&I) ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
Inspections ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Misbranding ,
Opioid ,
Orphan Drugs ,
Over The Counter Drugs (OTC) ,
PDUFA ,
Public Health ,
Real World Evidence ,
User Fees
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
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
5/11/2022
/ Biosimilars ,
BsUFA ,
CDRH ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Diversity ,
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FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
GDUFA ,
Generic Drugs ,
Inspections ,
Labeling ,
Medical Device User Fee Program (MDUFA IV) ,
Misbranding ,
PDUFA ,
Pharmaceutical Industry ,
Popular ,
Waivers
On October 1, 2018, in response to concerns about the risks of cyberattacks on patient medical devices, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb, M.D. announced the release of a cybersecurity...more