The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more
7/5/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
2/6/2023
/ Biologics ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Legislative Agendas ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Safety Inspections ,
Supply Chain
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
1/14/2020
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
10/17/2019
/ 21st Century Cures Act ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software
On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more
6/20/2018
/ Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Labeling ,
Manufacturers ,
Medical Devices ,
Premarket Approval Applications ,
Safe Harbors
On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more
This week, the FDA published final guidance outlining the agency’s current thinking with respect to the classification of products as drugs or devices, respectively. The final guidance summarizes the agency’s position with...more
On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more
This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more