A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more
1/3/2024
/ Cosmetics ,
Food and Drug Administration (FDA) ,
GAO ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Labels ,
Regulatory Requirements ,
Reporting Requirements ,
Responsible Party ,
Risk Management ,
Serious Harm Standard
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
7/21/2022
/ Birth Control ,
Dobbs v. Jackson Women’s Health Organization ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Roe v Wade ,
SCOTUS
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
9/17/2019
/ 21st Century Cures Act ,
Biologics ,
Biopharmaceutical ,
Drug Testing ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GAO ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Life Sciences ,
OMB ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Right to Try
FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more