The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more
2/22/2024
/ Comment Period ,
Draft Guidance ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Remote Proceedings
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
10/31/2023
/ Comment Period ,
FDA Approval ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more
8/23/2023
/ Comment Period ,
Cosmetics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Listing Rules ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Identifiers ,
Product Labels ,
Product Packaging ,
Registration Requirement
Introduction -
Effective January 1, 2022, food manufacturers must now comply with the U.S. Department of Agriculture ("USDA")'s National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (the "BE Disclosure Standard"...more
The Background: Test manufacturers and labs are rushing to offer molecular and antibody tests for the novel coronavirus (COVID-19) to meet huge demand. Meanwhile, regulatory oversight during this national emergency has...more
The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks.
The Result: Over the last five years, the Food and Drug...more
3/14/2019
/ Cybersecurity ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Internet of Things ,
Manufacturers ,
Medical Devices ,
OIG ,
Popular ,
Premarket Approval Applications ,
Regulatory Requirements
On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more