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
The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more
Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more
4/14/2020
/ CARES Act ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Creditors ,
Crisis Management ,
Exports ,
Federal Funding ,
Financial Solvency ,
Food and Drug Administration (FDA) ,
Government Assistance ,
Imports ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Recessions ,
Research and Development ,
Restructuring ,
Supply Chain ,
Vendors ,
Webinars
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more
9/18/2019
/ Cybersecurity ,
Digital Health ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
PreCert Pilot Program ,
Precertification ,
Regulatory Oversight ,
Regulatory Requirements ,
Software ,
Software Developers ,
Voluntary Participation
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more
8/28/2019
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Manufacturers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software Developers ,
White Papers
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
In its Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule), FDA codifies its long-standing...more
Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more
This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency
The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more
The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more
The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more
On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more
The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more