News & Analysis as of

Food and Drug Administration (FDA) Safety Precautions

Bricker Graydon LLP

Ohio law prohibits COVID-19 vaccination mandates for public schools; Outlaws mandates of vaccines without “full” FDA approval and...

Bricker Graydon LLP on

On July 14, 2021, Governor Dewine signed House Bill (H.B.) 244 into law. The new law becomes effective 90 days after the governor’s signature. Under H.B. 244, public schools may not: ..Discriminate against an individual...more

Womble Bond Dickinson

Let the record reflect –Are you keeping the records required by the FSMA Produce Safety Rule?

Womble Bond Dickinson on

As part of the Food Safety Modernization Act (FSMA), the Produce Safety Rule outlines the regulatory requirements that apply to entities that grow, harvest, pack or hold fresh produce. Depending upon the amount of their...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 4

Hogan Lovells on

In Washington: President Trump left Walter Reed Medical Center Monday evening despite his personal doctor, Sean Conley, saying he “may not be entirely out of the woods yet.” In a memo on Tuesday, his doctor said the...more

Haug Partners LLP

Understanding the FDA’s Medical Products Clinical Trial Guidance amidst COVID-19

Haug Partners LLP on

Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more

Greenbaum, Rowe, Smith & Davis LLP

New Jersey Authorizes Pharmacists to Conduct COVID-19 Testing

There is substantial support for the view that reliable widespread testing is essential to the restoration of a semblance of normalcy in New Jersey when considering the impact of the COVID-19 pandemic.  In connection with...more

Hogan Lovells

FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for...

Hogan Lovells on

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more

Patrick Malone & Associates P.C. | DC Injury...

FDA warns surgeons against experimental robot-aided cancer operations

The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and...more

Hogan Lovells

Produce Safety Rule Inspections Will Begin Soon

Hogan Lovells on

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow...more

Hogan Lovells

FDA Issues Final Guidance on Mandatory Recall Authority under FSMA

Hogan Lovells on

The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | January 2018

FDA Announces Intent Not to Enforce Portions of FSMA - The U.S. Food and Drug Administration (FDA) has announced it will not enforce certain provisions of the Food Safety Modernization Act (FSMA) because the agency needs...more

McDermott Will & Emery

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

McDermott Will & Emery on

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Knobbe Martens

Cook Medical Issues Voluntary Global Recall of Beacon Tip

Knobbe Martens on

FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. ...more

Knobbe Martens

FDA Medical Device Safety Tracking System Reform

Knobbe Martens on

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more

Faegre Drinker Biddle & Reath LLP

What's Safety and Effectiveness Got to Do with Substantial Equivalence? FDA Clears it Up.

On July 15, 2014, FDA issued draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. We think of it as a...more

King & Spalding

U.S. Customs And Border Protection Announces Three New Members Of Commercial Targeting And Analysis Center

King & Spalding on

Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more

Polsinelli

Congress Passes Compounding Quality Act

Polsinelli on

The Senate approved a human prescription compounding bill (H.R. 3204) Monday by voice vote, sending it to President Obama for his signature. The bill had been in the works since last year, when a meningitis outbreak from...more

Snell & Wilmer

Malware in the Machines: Cybersecurity for Medical Devices and Hospital Networks

Snell & Wilmer on

Within the last week the Food and Drug Administration (FDA) issued a pair of Safety Communications directed towards the medical device and healthcare industries regarding cybersecurity. Computer virus and other malware...more

King & Spalding

FDA Issues Draft Guidance on Medical Device Recalls - How to Distinguish Recalls from Product Enhancements

King & Spalding on

On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes...more

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