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 -

Hatch-Waxman Venue: The New Narrow?

by Robins Kaplan LLP on

The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

Third Circuit Splits with the Seventh Over Standing To Sue For Alleged Inefficient Design of Eye Drop Dispenser

In a surprising decision and split with the Seventh Circuit, the Third Circuit recently held that plaintiffs have standing to sue for unfair trade practices under the theory that a manufacturer is obligated to optimize the...more

Guest post – Observations on FDA 3D Printing Guidance

by Reed Smith on

A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was...more

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

by Reed Smith on

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that...more

Cyber Risk News & Trends - December 2017

Cybersecurity This Month - Continued onslaught of phishing and travel threats - Internet data breaches threaten the usernames and passwords of billions of people, but bad actors find phishing is the most effective way...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

by Dorsey & Whitney LLP on

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more

Utah Federal Court Dismisses Birth Defect Failure to Warn Claim

by Reed Smith on

On December 5, 2017, Time Magazine announces its Person of the Year. The publisher called us a week or so ago to say we were PROBABLY going to be named Man (Person) (Blog) of the Year, but we would have to agree to an...more

Menu Labeling Update: Plans On-Track for Implementation in May 2018

On November 7, 2017, the U.S. Food and Drug Administration (FDA or the Agency) released the much-anticipated draft supplemental guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). The Draft...more

Food and Beverage News and Trends

by DLA Piper on

FDA issues draft guidance on the creation of GRAS panels. The FDA has issued draft guidance on the best practices for a manufacturer to follow when convening a panel of experts to evaluate whether a substance is “generally...more

Food Litigation Trends: New and Undefined Label Claims in 2017

by Pepper Hamilton LLP on

Part 1: Current Trends and Ingredient Claims - Class-action lawsuits involving the false advertising of food products continue to be one of the most active areas in class litigation. Originally published in Update...more

FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

by Goodwin on

Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of...more

FDA Webinar To Discuss the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.

by Goodwin on

Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the...more

New FDA Guidance On Determining Whether To Submit An ANDA Or A 505(b)(2) Application

The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications (ANDA) and 505(b)(2) applications. Both sections were added to the FD&C Act...more

A Practical Approach for Resolving the Pediatric Oncology Drug Labeling Crisis

An undisputed crisis exists due to the absence of adequate labeling for pediatric oncology drug products. Almost all drugs used to treat pediatric oncology patients were approved over decades ago and knowledge of pediatric...more

Soy Vey! FDA May Revoke Soy’s Heart Health-Claim

by Reed Smith on

The FDA has called into question its health claim finding a link between consumption of soy protein and reduced risk of heart disease. Since 1999, the FDA has allowed manufacturers and advertisers to label soy products with...more

Eleventh Circuit Affirms Preemption of HRT Complaint

by Reed Smith on

Today, December 1, 2017, is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio. That is fitting, given our...more

Are EpiPens Friend or Foe?

7 Deaths Associated With Medical Device - EpiPens exist to save lives or stave off severe allergic reactions to drugs, foods, insect bites and other causes of anaphylaxis. They are pocket-sized cylindrical devices that, in...more

AD-ttorneys@law

by BakerHostetler on

Once completely obscure, fidget spinners are now a thing. Meaning that their existence, if not their actual purpose, has become known to you. Dubbed by The New York Times “a Hula Hoop for Generation Z,” the fidget spinner...more

The Latest Trends in Drug Monopolies

by Zelle LLP on

Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly...more

Unavoidably Unsafe PMA Medical Devices

by Reed Smith on

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related...more

Updates on Coherus pegfilgrastim and other biosimilar efforts

by Goodwin on

We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. ...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

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