The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
9/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Medical Supplies ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Supply Chain
Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to...more
Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...more
7/2/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Commercial Speech ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Drug Pricing ,
Drug Wholesaling ,
Final Rules ,
First Amendment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Transparency ,
Trump Administration
The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency...more
Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more
9/18/2015
/ Animal Food ,
CGMP ,
Farms ,
Federal Register ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Public Meetings ,
Recordkeeping Requirements ,
Risk Assessment ,
Risk-Based Approaches