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

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

ABA Resolution 105 on Punitive Damages Is Dead for Now

On the eve of the ABA's Annual Meeting next week, the ABA's Standing Committee on Medical Professional Liability announced its withdrawal of proposed Resolution 105 from consideration by the ABA House of Delegates. The...more

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

Modernizing and Coordinating the Regulatory System of Biotechnology Products

On July 2, 2015, the U.S. Office of Science and Technology Policy (OSTP) of the Office of the President issued a memorandum to initiate a process to coordinate, update and modernize the federal regulatory system governing...more

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule...more

U.S. House Passes GMO Labeling Legislation

Today the Safe and Accurate Food Labeling Act of 2015 passed the House, in a vote of 275 to 150 (more information here). Still a hot-button issue, opposition to the Act is emotionally charged, with those opposed to the bill...more

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

Cures Are on the House: House Passes 21st Century Cures Act, but Senate Awaits

On July 10, 2015, the House of Representative passed H.R. 6, the 21st Century Cures Act (“Cures Act”), with strong bipartisan support, by a vote of 344-77. This medical innovation reform legislation represents the culmination...more

Patients' Voices Carry: Drug Development Increasingly Driven by Patients' Needs and Concerns

With the recent announcement of Sarepta’s filing for approval of its drug, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD), coming on the heels of BioMarin’s announcement a few months earlier of a similar...more

Also In The News - Health Headlines - July 2015

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

A Fractured Federal Circuit Panel Interprets The Biosimilars Patent Resolution Procedures

On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more

House Passes Voluntary GMO Labeling Bill

The U.S. is a step closer to enacting a consistent, national approach to certifying and labeling genetically modified (GMO) foods. On July 23, 2015, the U.S. House of Representatives passed H.R. 1599, the Safe and Accurate...more

Health Update - July 2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

Food and Beverage Alert (US)

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - House committee approves law to bar states from requiring GMO labeling. On...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

Unhappy Meals – Who Regulates Food Advertising for Kids?

Food labeling and advertising is a hot topic these days — from whether genetically modified ingredients should be disclosed to when and how companies can make the claims that their products are “all natural.” How companies...more

Little Reprieve for Prisoner Zyprexa Suit

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern...more

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

Federal Circuit Interprets Biosimilars Law in Amgen v. Sandoz

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the...more

Federal Circuit Interprets BPCIA for First Time

The U.S. Court of Appeals for the Federal Circuit today decided issues of first impression relating to the statutory interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In a split decision in...more

1,276 Results
|
View per page
Page: of 52

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×