On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more
California Bans Several FDA-Authorized Food Additives; New York May Soon Follow -
On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety...more
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
10/30/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Customs and Border Protection ,
DSCSA ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
MDRP ,
Medicaid ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more
FDA joins industry groups in opposing Prop 65 cancer listing for BPA -
Chemical Watch -
The US Food and Drug Administration has joined a pair of industry trade groups in opposing the potential listing of bisphenol A as...more
For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief,...more
Food Safety
On March 9, the European Food Safety Authority announced that there is no evidence that food is a source or transmission route for coronavirus. FDA has taken the same position, both in a stakeholder briefing held...more
FDA issued a Compliance Policy delaying enforcement of the DSCSA’s saleable returns verification requirement by one year. So now, instead of wholesale distributors having to comply by November 27, 2019, FDA will exercise...more