The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders.
On September 22, 2023, the US...more
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others.
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
1/16/2023
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biosimilars ,
Cosmetics ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Inspections ,
Interchangeability ,
Manufacturing Facilities ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform
The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers.
Key Points:
..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more
Drug Pricing Reform: President Biden, in remarks delivered on Sept. 27, 2022, touted insulin pricing provisions in H.R. 5376, the Inflation Reduction Act of 2022 (IRA), which became law on Aug. 16, 2022. He referred to...more
The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress.
Key Points:
..Congress authorized FDA to...more
With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more
2/17/2021
/ Administrative Law Judge (ALJ) ,
Antitrust Provisions ,
Biden Administration ,
Broadband ,
CFIUS ,
Climate Change ,
Commodities ,
Congressional Oversight ,
Cybersecurity ,
Data Privacy ,
Energy Policy ,
Energy Sector ,
Environmental Policies ,
FCC ,
Health Care Providers ,
Investigations ,
Legislative Agendas ,
Life Sciences ,
Net Neutrality ,
Regulatory Agenda ,
Sanctions ,
Securities Regulation ,
White Collar Crimes
The US regulators have been particularly focused on new players in the health tech space and the novel regulatory issues their products present within the existing legal framework. While the market is ripe with opportunity...more
Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices.
Background -
On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more
New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients.
On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more
Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines.
Key Points:
..Congress authorized FDA to collect increased total annual user...more
Agency works to speed approvals and improve access to generic prescription drugs.
In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more
Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” -
On January 18, 2017, the US Food and Drug Administration (FDA or...more
The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens.
On December 13, 2016, President Obama signed into...more
New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016.
On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more
Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule.
On May 10, 2016, the U.S. Food and...more
The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion.
On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more
FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn?
On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more
Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests.
As the Food and Drug...more
In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices.
On March 3, 2014, the Food and Drug Administration (FDA) released a...more
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more
FDA report demonstrates support for personalized medicine and more efficient regulatory pathways.
In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more