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 -
News & Analysis as of

Court Orders Entry of Final Judgment of Invalidity in Ongoing Janssen v. Celltrion BPCIA Dispute

A number of new developments arose this past week in the ongoing litigation between Celltrion and Janssen. (C.A. No. 1:15-cv-10698, D. Mass.) As discussed, the dispute centers around Inflectra®, which is Celltrion’s FDA...more

FDA to Redefine “Healthy”

The term “healthy” as commonly used is quite subjective—meaning different things to different types of consumers. Culturally, there are sometimes fast-changing trends about what is healthy—foods rejected by consumers a few...more

The Changing Meaning of Healthy: FDA Seeks Public Input About Healthy Foods

In the 1990s, food had to be low in fat in order to be considered healthy. Those were the days of Snack-Wells cookies and fat-free salad dressings. How times have changed. Now health professionals consider many higher-fat...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on Interchangeability Guidance

FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 –...more

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.” Today, it announced the beginning of the formal process to make changes to the definition of the...more

Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic...more

FDA Guides Industry For Use Of “Healthy” On Food Packaging

Yesterday, the Food and Drug Administration (“FDA”) announced guidance regarding using the term “healthy” in the labeling of human food products. As background, the FDA issued final rules updating the Nutrition Facts label...more

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more

Blog: Federal Court Gives Teeth to Operational Efforts Covenant in Sanofi/Genzyme Earn-Out Dispute

We keep a close eye on developing cases regarding earn-outs and contingent payment rights in light of the prevalent use of these arrangements in life sciences deals and their increasing use in non-life sciences deals. On...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

Samsung Bioepis Seeks Regulatory Approval for an Adalimumab Biosimilar in Europe and South Korea

Samsung Bioepis is reportedly seeking regulatory approval to sell a biosimilar version of Humira® (adalimumab) in South Korea. Also, in July 2016, Samsung Bioepis reported that the EMA had accepted its Marketing Authorization...more

FDA Denies AbbVie Citizen Petition on Fifth Amendment Takings

On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira...more

Thompson Coburn presents a CLE on FSMA, looming deadlines and new regulations: Is the food industry ready?

The US Food and Drug Administration continues its ongoing implementation of the Food Safety Modernization Act of 2011 (FSMA). The law, which aimed to take the first hard look at the American food supply in decades, has...more

FDA Approves Amjevita -- Amgen's HUMIRA® Biosimilar

On September 23, 2016, the FDA approved Amgen's application to market Amjevita (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab) fully human anti-TNF-a antibody. This marks the fourth biosimilar approved by the...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

Searching for Causation in ACTOS Complaint

How explicitly must a complaint sounding in antitrust allege causation? At oral argument last week, the Court of Appeals for the Second Circuit evaluated the sufficiency of the plaintiffs’ allegations that certain Takeda...more

Congressional Hearings Focus on Health Policy Issues - September 2016

A number of recent Congressional hearings have focused on health policy issues, including: ..Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and...more

Can Antitrust Prevent Excessive Drug Price Increases?

The antitrust agencies are often asked to intervene in markets where pricing appears to be excessive to help protect consumers and stabilize markets. In the drug arena, healthcare providers, consumers and politicians have...more

AGG Food and Drug Newsletter - September 2016

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

EPA IG's Concerns About Oversight of Hospital Disinfectants Reinforces Need for Robust Infection Control Programs

On September 19, 2016, the Inspector General (IG) for the Environmental Protection Agency (EPA) issued the latest in a long line of reports identifying flaws in EPA’s process for ensuring the efficacy of hospital-grade,...more

Aralez’s YOSPRALA wins FDA approval

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

FDA to Hold Public Meeting on Biosimilar User Fees

On September 13, 2016, FDA announced that it will hold a public meeting on October 20, 2016, from 9 a.m. to 2 p.m. at the FDA White Oak Campus in Silver Spring, Maryland, to discuss recommendations for the reauthorization of...more

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