Administrative Agency Science, Computers & Technology

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FDA Finalizes Key Guidance Documents on Biosimilars

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The...more

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

SEC Issues New Cybersecurity Guidance for Investment Funds

On April 28, the Securities and Exchange Commission (SEC) Division of Investment Management (the “Division”) published a Guidance Update setting forth cybersecurity concerns and advice for the registered investment ...more

Consent to Disclose Information in Response to a Consumer Complaint – Guidance from Canada

Not infrequently, customers may resort to consumer affairs columnists and other third parties, such as consumer advocacy groups, in order to resolve issues that they are having. In these circumstances, is there implied...more

Tomorrow is Another One-A-Day: FDA Guidelines Preempt Vitamin Claims, but Consumer Class Still Has Opportunity to Supplement

Although consumer class actions in California are dime-a-dozen, a recent Northern District of California case involving One A Day vitamins stands out because it demonstrates how federal regulations can preempt certain state...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

Chinese Legislature Adopts Amendments to Drug Administration Law

China’s top legislature, the Standing Committee of National People’s Congress, recently approved the amendments (the “Amendments”) to the Drug Administration Law. The Amendments, effective as of April 24, 2015, cover the...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

Transgenic Salmon: A Primer on FDA Food Safety Regulations

When Meriwether Lewis tasted his first roasted morsel of a fresh Chinook salmon at a Shoshone camp along the Lemhi River (in modern day Idaho), he ate it with “very good relish.” It convinced him that “we were on the waters...more

Department of Labor Says "Transparent Government" Begins With...Transparent Data about Businesses?

We’ve reached almost the end of April, and the long delayed, new FLSA regulations are still percolating somewhere in deep inside the DOL. So what has the agency been up to instead? Last month, as part of the annual “Sunshine...more

Federal Circuit Patent Updates - April 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

LabMD Litigation Updates

We have been following this case closely. On April 16, the administrative law judge in the FTC v. LabMD case denied LabMD’s request to exclude the FTC from introducing new evidence into the proceeding regarding how Tiversa...more

Pharmacy Pays $125,000 for Failure to Properly Dispose of Paper Records

Cornell Prescription Pharmacy (“CPP”), a Colorado single-location pharmacy, has agreed to pay $125,000 to the United States Department of Health and Human Services, Office for Civil Rights to settle alleged violations of the...more

EPIC files suit against FAA for lackadaisical drone privacy regulations

On March 31, 2015, the Electronic Privacy Information Center (EPIC) filed a petition against the Federal Aviation Administration (FAA) with the D.C. Circuit court asking that the court review the FAA’s proposed rule on...more

DPR Proposal for Right-to-Know Notifications Prior to Soil Fumigant Applications Could Have Far-Reaching Implications

On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more

FTC Finalizes First Privacy Settlement Against a Retail Tracking Firm

In a first-of-its-kind enforcement action, the Federal Trade Commission (FTC) on Thursday voted along party lines to settle deception allegations against Nomi Technologies (Nomi), a company whose technology allows retailers...more

FCC Denies E-Rate Appeal in Scorching Order

On April 15, after a multi-year investigation arising from events in 2004-2008, the Chief of the Telecommunications Access Policy Division (TAPD) of the FCC’s Wireline Competition Bureau issued an Order denying appeals by an...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

District Court Declines to Lift Stay Even After Patent Trial and Appeal Board Issued Written Decision on CBM Petitions

The district court stayed several consolidated cases pending certain proceedings before the Patent Trial and Appeal Board ("PTAB"). In the order granting the stay, the district court stated: "Upon issuance of a final decision...more

Senju Pharm. Co., Ltd. v. Metrics, Inc.

Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more

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