Administrative Agency International Trade Science, Computers & Technology

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Filing Waiver of Service Triggers One-Year IPR Bar Date - The Brinkmann Corporation v. A&J Manufacturing

Addressing the issue of standing to present a petition, the Patent Trial and Appeal Board (PTAB or Board) granted institution of an inter partes review (IPR), finding that the petition filed within one year of filing waiver...more

OFAC on Bitcoin—Learning Before Actively Regulating

Before a government agency issues regulations implementing a new law—or applies existing regulations to a new technology—it has to do some groundwork. The agency will interpret its authorizing legislation and executive...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

Yesterday the OIG posted a report entitled “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs” in response to a Congressional request expressing concerns about the safety and quality of...more

New Changes to U.S. Design Patent Law

American-based companies seeking protection for industrial designs will soon be encountering significant changes. On May 13, 2015, the United States will become a contracting party to the Geneva Act of the Hague Agreement...more

PTO Revival Rulings Are Not Subject to Collateral Attacks by Third Parties - Exela Pharma Sciences, LLC v. Lee

Addressing whether third parties have the right to challenge a patent revival ruling by the U.S. Patent and Trademark Office (PTO) under the Administrative Procedure Act (APA), the U.S. Court of Appeals for the Federal...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FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical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

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

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

FCC Enters Into $25 Million Settlement Following Cell Phone Carrier Data Breach

On April 8, the Federal Communications Commission (FCC) announced a $25 million settlement with an international telecommunications carrier concerning the unauthorized release of the personal information of nearly 280,000...more

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Assuring Regulatory Compliance Doesn’t Get Lost in Translation

With the expansion of large multinational corporations into developing countries such as Russia, Brazil, India, Mexico and China, a proliferation of global regulatory enforcement actions, including anti-bribery and...more

Canada Issues First Penalties Under Anti-Spam Law

CRTC imposes over US$900,000 in fines against two companies, reminding U.S.- and foreign-based businesses about possible liability under Canada’s Anti-Spam Law - This month marks the issuance of the first two enforcement...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

On the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

China Issues Revised Hazardous Chemicals Inventory; Enforcement Likely to Increase

On February 27, 2015, ten departments under China’s central government jointly issued a revised list of hazardous substances, the Inventory of Hazardous Chemicals (“Inventory"), which will become effective May 1, 2015. ...more

Can the U.S. – EU Safe Harbor Weather the Storm?

On 24 March, the Court of Justice for the European Union (CJEU) heard argument on a case that could significantly impact, if not invalidate altogether, the Safe Harbor framework that facilitates the flow of personal data from...more

Restrictions Eased for Communications-Related Items Exported to Sudan

On February 18, 2015, in a coordinated action, the Commerce Department's Bureau of Industry and Security (BIS) and Treasury Department's Office of Foreign Assets Control (OFAC) announced and implemented changes to the...more

EUROPE: EU-US data flows at risk? European Court of Justice today heard Facebook case.

Yesterday, the Schrems v. Irish Data Protection Commission case was brought before the Court of Justice of the European Union (‘CJEU’) for an oral hearing, following referral by the Irish High Court. While the final ruling by...more

U.S. International Trade Commission Institutes Investigation Under 100-Day Pilot Program Examining Complainant’s Standing to File...

The U.S.I.T.C. instituted its first investigation under its 100-day pilot program for early determination of a specific potentially case-dispositive issue....more

The SEC and the Pharmaceutical Industry - Recent Commentary by the SEC's Enforcement Director Identifies Areas of SEC Focus...

Recently, the United States Securities and Exchange Commission’s (“SEC”) Enforcement Director, Andrew Ceresney (“Ceresney”), spoke to pharmaceutical compliance personnel at the CBI’s Annual Pharmaceutical Compliance Congress...more

Guest Blog Post: Changes to the Polish Data Protection Act

On 1st January 2015 amendments to the Polish Data Protection Act of 29th August 1997 came into force. These amendments (the “Amendments”) impact: (i) the role played by the “administrator bezpieczenstwa informacji,” (“DPO”)...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

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