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 -

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

FDA Announces Biosimilar User Fee Act Rates for FY2018

by Goodwin on

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug...more

Netherlands Adopts US FDA-based UDI System for Medical Devices

by Knobbe Martens on

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

AGG Food and Drug Newsletter - September 2017

by 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

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are...

by Arnall Golden Gregory LLP on

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more

United States ex rel Campie v. Gilead Sciences: Ninth Circuit Revives FCA Suit Despite Escobar’s “Demanding and Rigorous”...

The United States Court of Appeals for the Ninth Circuit unanimously reversed dismissal of a False Claims Act Complaint in United States ex rel. Campie v. Gilead Sciences. The most notable aspect of the case is that the panel...more

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures

by Hogan Lovells on

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

As Medical Food Industry Grows, So May FDA Scrutiny

by Baker Donelson on

On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The...more

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

by Arnall Golden Gregory LLP on

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and...more

Does the NAD’s Capillus Decision Baldly Contradict the FDA?

by Kelley Drye & Warren LLP on

On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case #6107). This case is unusual in that it addressed a challenge to a prescription-only medical device, and related closely...more

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

by Arnall Golden Gregory LLP on

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

by Arnall Golden Gregory LLP on

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July...more

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

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