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 Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

AGG Food and Drug Newsletter - July 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

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

First Extended-Range Intraocular Lens Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tecnis Symfony Intraocular Lenses (IOL) for treating cataracts. According to Abbott, the Tecnis Symfony lenses are currently the only lenses in the United...more

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

GMO Disclosures and Claims: A Possible End to the U.S. GMO Labeling Controversy?

On July 7, 2016, the U.S. Senate passed an important amendment to S. 764 to establish a mandatory nationwide labeling approach for genetically engineered (GE) foods, more popularly referred to as genetically modified...more

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally...more

FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”

Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more

FDA Issues Complete Response Letter for Sandoz’s Neulasta® Biosimilar

As we’ve previously reported, Sandoz is seeking approval of an aBLA for its proposed biosimilar to Neulasta® (pegfilgrastim), which is currently the subject of a BPCIA litigation (Civil Action No. 3:16-cv-02581 (N.D. Cal.)) ...more

Busy Week for Biosimilars Worldwide

United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is...more

ANDA Update - Volume 2, Number 2

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

Congress Passes GMO Labeling Bill – Preempting State Labeling Laws

In response to recent state efforts to regulate the labeling of food products containing genetically modified organisms (GMOs), the U.S. House of Representatives, on July 14, passed S. 764, a Senate-initiated bill...more

Washington Healthcare Update

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Launches Advisory Panels: On June 15, 2016, the U.S. Environmental Protection Agency (EPA) launched two advisory panels designed to facilitate small businesses to provide feedback to EPA...more

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

Food and Beverage News and Trends Series

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Beer trade group urges industry to adopt voluntary nutrition and calorie...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

What Type of Sale Constitutes an On-Sale Bar?

An invention cannot be patented if it was ready for patenting and was subject to a commercial offer for sale more than one year before the application was filed. This so-called “on-sale bar” can also be used to invalidate a...more

2,156 Results
|
View per page
Page: of 87
JD Supra Readers' Choice 2016 Awards

"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*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*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.
×