Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more
4/3/2025
/ Abbreviated New Drug Application (ANDA) ,
Applications ,
Compliance ,
Data Integrity ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
As a further update to our alert from March 27, the Trump Administration began mass layoffs at US health agencies on April 1....more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
1/22/2025
/ Artificial Intelligence ,
Biologics ,
Data Privacy ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management
A major new research paper has concluded what many doctors had long believed was true – that patients can be switched between reference (or name brand) biologics and biosimilars with no issues involving the safety profiles or...more
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
10/30/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Customs and Border Protection ,
DSCSA ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
MDRP ,
Medicaid ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more
10/25/2023
/ Affordable Care Act ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare ,
Premarket Approval Applications ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Oversight
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.”
This draft guidance is one of...more
The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more
On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more
FDA provides requirements that will allow for a much quicker authorization of “booster shots” for existing vaccines for use against variants or mutations of the coronavirus.
The FDA has just released an updated Guidance...more
Late yesterday, November 17, 2020, the FDA issued an Emergency Use Authorization (EUA) to Lucira Health for an All-In-One Test Kit for prescription home use in individuals 14 years of age or older.
After over 8 months of...more
The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy.
From...more
In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change.
In the new announcement, HHS...more
The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities.
...more
COVID-19 testing has been a problem since the earliest days of the pandemic. In those days – only a few months ago – the types of tests and the locations where testing might be available were very, very limited. Indeed, in...more
On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus.
The EUA was issued to Illumina,...more
The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the...more
On Friday, May 22, 2020, the USDA and FDA jointly released recommendations to address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture...more
“Testing, Testing, Testing” is the new mantra. The politicians and the press are full of the few reports of testing successes and the many reports of testing failures throughout the country and around the world. So in light...more
On May 8, 2020, the FDA announced that it had authorized the first COVID-19 diagnostic test that can be used to collect saliva in the home. Specifically, the FDA issued an emergency use authorization (EUA) to the Rutgers...more
On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous February 29, and March...more
As the United States begins to see positive signs that mitigation efforts such as stay-at-home orders and social distancing are working, the question of when people can return to work and resume normal activities is one of...more
Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices.
In this new Guidance, the FDA says it is expanding “the availability and capability of sterilizers, disinfectant...more