Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more
Ethylene oxide (“EtO”), one of the most widely used and effective substances for sterilizing medical products and devices, has come under intense scrutiny by the Environmental Protection Agency (“EPA”), the Food and Drug...more
On January 15, 2020, the House Energy & Commerce Committee, Subcommittee on Health held a hearing entitled “Cannabis Policies for the New Decade.”
Government witnesses testified from:
• the Drug Enforcement...more
1/17/2020
/ Cannabidiol (CBD) oil ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Dietary Supplements ,
Expungement ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Marijuana-Infused Edibles ,
Medical Marijuana ,
National Institute of Health (NIH) ,
Regulatory Agenda ,
Research and Development ,
Schedule I Drugs
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
1/7/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Enhanced Penalties ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory History ,
Regulatory Requirements ,
Supply Chain
Effective upon Publication, USDA’s Interim Final Rule Sets Forth One Important Part of the Regime for Marketing Hemp Products in the United States -
This week, the U.S. Department of Agriculture (USDA) issued an interim...more
11/1/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Comment Period ,
Controlled Substances ,
DEA ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Marketing ,
Public Comment ,
Regulatory Requirements ,
State and Local Government ,
Tribal Governments ,
USDA
Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more
The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements -
On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more
5/14/2019
/ Administrative Authority ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
Drug Pricing ,
Final Rules ,
First Amendment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency
On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more
4/10/2019
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Medical Devices ,
Popular ,
Public Comment ,
Regulatory Agenda ,
Software
Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds -
On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more
4/8/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Enforcement ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Related Businesses ,
Public Comment ,
Public Health ,
Public Meetings ,
Public Notice ,
Regulatory Agenda ,
Regulatory Authority ,
Warning Letters
Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
1/23/2019
/ Comment Period ,
Cybersecurity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Mobile Medical Applications ,
Popular ,
PreCert Pilot Program ,
Precertification ,
Public Comment ,
Software ,
Telemedicine
On December 11, 2018, Dr. Scott Gottlieb, the Commissioner of the Food and Drug Administration (“FDA”) issued a statement announcing the agency’s new actions to advance its biosimilars policy framework. Tucked into one of...more
On December 3, 2018, the Federal Trade Commission (“FTC”) submitted a comment on the Food and Drug Administration’s (“FDA’s”) revised draft guidance regarding the process for reviewing 505(q) citizen petitions (“Revised Draft...more
Last week, the U.S. Food and Drug Administration (FDA) issued a final order classifying in vitro diagnostic (IVD) tests that utilize next generation sequencing (NGS) to profile cancer tumors into Class II (special controls)....more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors -
On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
6/21/2018
/ Final Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Labeling ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Required Communications ,
Safe Harbors
On Friday, May 11, the Trump Administration released a 39-page “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (“Blueprint”). The Blueprint raises in very broad strokes potential Administration strategies to...more
In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more
On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more
1/23/2017
/ 21st Century Cures Act ,
Draft Guidance ,
FDAMA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCEI ,
Investigational New Drug Application (IND) ,
Manufacturers ,
Material Dissemination ,
Payor Contracts ,
Safe Harbors ,
Section 502
Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more
Program Has Broad Reach -
On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more
The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more
On July 6, 2016, the European Chemicals Agency (ECHA) issued a call for evidence from relevant stakeholders to gather information on the uses of formaldehyde releasers. ECHA intends to issue a report to inform the...more