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

Kyle Bass Wins at the PTAB

On October 21, 2016, the PTAB issued two final written decisions invalidating claims of U.S. Patent No. 7,056,886 (“the ’886 patent”), covering Shire’s drug Gattex® which were challenged by Kyle Bass last year. Although Bass...more

Check the Box to Avoid Food & Beverage Packaging Litigation

Shagha Tousi, a partner in Nutter’s Litigation Department and a member of the firm’s Business Litigation and Product Liability and Toxic Tort Litigation practice groups, addressed product packaging litigation in the food and...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

Mylan and the Biosimilars Council Urge Supreme Court to Overturn Amgen v. Apotex

On October 14, 2016, Mylan Pharmaceuticals and the Biosimilars Council, a subsidiary of the Generic Pharmaceuticals Association (GPhA), filed amicus briefs in support of granting review in Apotex v. Amgen, No. 16-332. As...more

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014). More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions...more

It’s Hunting Season. For Unicorns? Lawsuit Against Theranos Signals Trend In Investors Going After Late-Stage Start-ups

Last week brought more bad news for private blood testing company Theranos Inc., as San Francisco-based Partner Fund Management L.P. (“PFM”) launched a suit claiming that it was duped into making a $96.1 million investment in...more

AGG Food and Drug Newsletter - October 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

More Than the Leaves Are Changing: Clinical Trial Research Regulations and Policies Get a Fall Makeover

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting,...more

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson & Johnson recently warned its customers of a cybcersecurity issue with one of its insulin pumps, potentially leaving thousands of users vulnerable.  According to Johnson & Johnson’s letter, “a cybersecurity issue with...more

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

Naturally Misleading? Ninth Circuit Keeps “All Natural” Fruit Labeling Dispute Alive

Does a food label advertising a product as “all natural fruit” mislead consumers when that product contains artificial preservatives? That is the question presented in Brazil v. Dole Food Co. Inc., which the Court of Appeals...more

OFAC and BIS Changes to Cuba Sanctions Further Ease Trade and Travel Restrictions

On October 14, 2016, the Treasury Department’s Office of Foreign Assets Control (OFAC) and the Commerce Department’s Bureau of Industry and Security (BIS) published another round of amendments to the Cuban Assets Control...more

Don’t Forget About FTC Compliance: Substantiating Claims to Avoid Misleading Consumers

Life sciences companies regularly review their labeling and promotional materials to ensure compliance with Food and Drug Administration requirements. FDA makes its Warning Letters publicly available, and failure to correct...more

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion

Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...more

Navigating the Maze of E-Cig Marketing Regulations

Federal regulators, and states, counties and cities throughout the country, are enacting new laws, rules and regulations in the e-cigarette marketing space. How can e-cig manufacturers and related marketing affiliates...more

Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection

In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an...more

Homeopathic Teething Products Linked to Child Deaths, FDA Says

Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Reg

On September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register ....more

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more

FDA Announces Initiative to Redefine “Healthy” Claim for Food Labeling

The U.S. Food and Drug Administration (“FDA”) announced in September that it is considering how to redefine the term “healthy” as a nutrient content claim for the labeling of human food products. The FDA issued a guidance...more

U.S. Authorities Amend Cuba Sanctions Regulations

On October 17, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) and the Commerce Department’s Bureau of Industry and Security (BIS) issued new amendments to the Cuban Assets Control Regulations (31...more

De-certifiably Natural – Ninth Circuit Finds “All Natural” Label May be Misleading While Upholding Class Decertification

The Ninth Circuit Court of Appeals recently reversed in part and affirmed in part a Northern District of California ruling concerning the “All Natural Fruit” labeling on Dole’s packaged fruit products. Brazil v. Dole Packaged...more

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