Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more
Could Help to Streamline Development and Approval -
On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more
1/16/2023
/ Artificial Intelligence ,
Biotechnology ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Digital Health ,
Drug Distribution ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investment ,
Machine Learning ,
Pharmaceutical Industry ,
Telemedicine
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
The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more
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