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

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) - Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation suspension); U.S. Patent No....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

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

Washington Healthcare Update

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

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

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