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Medical Devices › Investigational New Drug Application (IND)

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

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The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

K&L Gates LLP

Health Care Triage: Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

K&L Gates LLP on

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more

Alston & Bird

Alston & Bird Health Care Week in Review - May 2022 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Womble Bond Dickinson

Emergency Use Authorization Issued for COVID-19 Antibody

Womble Bond Dickinson on

On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more

Bass, Berry & Sims PLC

How Should Institutions Conducting Research Respond to COVID-19?

Bass, Berry & Sims PLC on

As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more

Cozen O'Connor

First Circuit Permits Antitrust Claims for Improperly Listing a Device Patent on the FDA’s Orange Book to Move Forward

Cozen O'Connor on

In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more

Hogan Lovells

To certify or not to certify? FDA has answered the question

Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

Troutman Pepper

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

Troutman Pepper

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Troutman Pepper on

Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more

Hogan Lovells

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Hogan Lovells on

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2016

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2015

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Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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