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Blog: FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more

FDA applies postmarketing requirements to evolving medical device cyber-risks – key messages to manufacturers

With incursions on cybersecurity occurring daily across a variety of platforms, cybersecurity risks are top of mind for FDA and for the device industry....more

FDA issues guidance on cybersecurity risk management for medical devices

Friday (January 22, 2016), the Food and Drug Administration (FDA) published draft guidance for medical device makers on the importance of including cybersecurity measures in approved products. Further, the guidance highlights...more

FDA Issues Draft Guidance on Postmarket Cybersecurity of Medical Devices

On January 15, 2016, the Food and Drug Administration (“FDA”) released a draft guidance entitled, “Postmarket Management of Cybersecurity in Medical Devices,” outlining recommendations that device manufacturers should...more

Senate HELP Committee Minority Staff Report Places Blame on Manufacturers, Hospitals, and FDA Regarding Duodenoscope-Linked...

On January 13, 2016, Senator Patty Murray (D-WA), Ranking Member of the United States Senate Health, Education, Labor, and Pensions (“HELP”) Committee, released a Minority Staff Report detailing the results of a year-long...more

Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and...

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more

Keeping it Legal: Managing FDA Compliance for Consumer-Generated Content

Social technology platforms allow manufacturers to leverage consumer-generated content about their products (“CGC”) more easily than ever before. Such CGC generally takes the form of written testimonials and product reviews...more

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

The FDA Gets Pulled Into the "Natural" Labeling Fray: Surprise Move May Change the Food Fight

In a surprising change of tack, the U.S. Food and Drug Administration (FDA) announced Tuesday that it will accept public comments on the use of "natural" claims on food labels. The move, which may signal FDA's intention to...more

GNC lawsuit reflects FDA’s crackdown on dietary supplement industry

The Oregon Attorney General’s Office hit General Nutrition Centers (GNC) with a lawsuit last week alleging that the company knowingly sold supplements that contained FDA-banned ingredients. The action should serve as a...more

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...more

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Food Safety’s Shifting Paradigm

The recent news that Stewart Parnell, convicted former Peanut Corporation of America CEO, is facing a possible life sentence as a consequence of his role in the nine deaths and hundreds of illnesses caused by PCA’s salmonella...more

First FDA FSMA Rules Have Landed; More Likely to Follow by End of Year

Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive...more

FDA Issues Draft Guidance and Proposed Rule on the Nonproprietary Naming of Biological Products

On August 28, 2015, FDA issued a draft guidance document and a proposed rule addressing the nonproprietary naming of biological products. Because nonproprietary naming can have substantial effects on the market for biosimilar...more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Hidden Costs of Common Beauty Treatments?

The “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions...more

The Medicines Company v. Hospira - Preparation of validation batches by a contract manufacturer for FDA submission creates an...

On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

FDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018

Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over...more

Cosmetic Safety Legislation Introduced, Again

In what is the latest in a line of Congressional proposals to beef up the federal government’s authority to regulate cosmetics, Senator Dianne Feinstein (D-CA), has proposed a bill aimed at dramatically increasing Food and...more

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