News & Analysis as of

The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Rulings, Orders, Settlements – August 4, 2017

by Perkins Coie on

Court Denies Motion to Dismiss for Non-Functional Slack-Fill Class Action - White v. Just Born, Inc., No. 2:17-cv-4025 (W.D. Mo.): The Court issued an order denying Defendant’s motion to dismiss this putative...more

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

FDA Approves First Avastin Biosimilar

FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi...more

FDA Embraces Real-World Evidence in New Final Guidance

by Hogan Lovells on

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Adopts 2017 NAICS Codes For TRI: On August 16, 2017, the U.S. Environmental Protection Agency (EPA) announced that it is updating the list of North American Industry Classification System (NAICS) codes...more

Recall Highlights Medical Device Cybersecurity Issues

by Knobbe Martens on

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

Global Privacy & Cybersecurity Update Vol. 15

by Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...more

FDA Approves Amgen’s Biosimilar of Avastin®

by Goodwin on

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of...more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

by Reed Smith on

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

FDA Seeks Stakeholder Input on Regulatory Reform Efforts

by K&L Gates LLP on

On September 8, 2017, the Food and Drug Administration (“FDA”) became the latest in a line of federal departments and agencies to seek public input on approaches to modify regulations and reduce the burden on stakeholders....more

FDA Accepts Applications for Rituximab and Filgrastim Biosimilar Candidates

by Goodwin on

According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for...more

The Third Circuit Fosamax Preemption Error Has Got to Go

by Reed Smith on

Last week we were going through the regulatory record of a drug that is now the subject of mass tort litigation. This effort is central to assembling, per the SCOTUS Wyeth v. Levine case, “clear evidence” that the FDA would...more

Speedboat RS2 Endoscopic Device Receives FDA Clearance

by Knobbe Martens on

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel....more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

by Arnall Golden Gregory LLP on

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

FDA Commissioner Touts Seamless Clinical Trails, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., spent considerable...more

AD-ttorneys@law

by BakerHostetler on

Abbott Nutrition did something unique. It added a new ingredient to its Similac Pro-Advance and Pro-Sensitive infant formulas that, until now, had only been available in human breast milk: 2’-fucosyllactose human milk...more

FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred...more

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

FDA Finalizes Guidance on Interoperable Medical Devices

by McGuireWoods LLP on

Recently, the U.S. Food and Drug Administration (FDA) finalized guidance summarizing its recommendations for interoperable medical devices, or devices that are connected to each other and to other technology. Noting the...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

Food and Beverage News and Trends - September 2017

by DLA Piper on

Report on consumer and retailer hurdles regarding electronic disclosure of GMO ingredients. - Consumers and small retailers face “key technological challenges” regarding electronic disclosure of GMO ingredients in foods,...more

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