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Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

Scripts Newsletter - October 2014

In this issue: - Health Care Decisions — Who Decides? - Medical Software Licensing — Tips from the Trenches - An Ounce of Prevention — The Importance of Periodic Corporate Audits - ACA -...more

The SAB Enters the “Waters of the United States” Fray: Guess Which Side the Scientists Support

The Science Advisory Board has now provided its advice to EPA and the ACOE concerning their proposed rule clarifying the definition of “waters of the United States” under the Clean Water Act. In a brief letter that can only...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

New draft regulation on resolution of disputes between electronic communication operators

The Italian Communication Authority (AGCOM) published a new consultation on a draft regulation relating to the resolution of disputes between electronic communication operators....more

California Federal District Court Grants Partial Dismissal to Suit Alleging Violations of the Endangered Species Act

Earlier this month, a federal district court in California partially granted motions to dismiss a second amended complaint filed by the Center for Biological Diversity and the Pesticide Action Network alleging that the...more

Court Allows ESA Claims Involving Oversight of Pesticides to Move Forward

In Center for Biological Diversity v. Environmental Protection Agency, No. 11-cv-00293-JCS, plaintiffs alleged that the Environmental Protection Agency (EPA) violated section 7 of the Endangered Species Act by failing to...more

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Scientists Weigh In On Biogenic Carbon Accounting Debate

On June 19, 2014, over 90 scientists sent a letter to EPA urging the Agency to move forward under its Tailoring Rule by "1) moving beyond the flawed assumption that bioenergy is inherently carbon neutral; 2) rejecting the...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

FCC Regulations On Phone Call Captioning Held To Be Arbitrary and Capricious

On June 20, 2014, the D.C. Circuit Court of Appeals vacated two FCC regulations on phone call captioning technology designed for the hearing impaired, holding that the rules were made arbitrarily and capriciously in violation...more

Status of 340B “Mega-Rule” in Question as HHS Decides How to Proceed with Vacatur of Orphan Drug Rule

For over a year, participants in the 340B Drug Pricing Program (340B Program) and others have been waiting for the release of the so-called proposed “Mega-Rule” by the Department of Health and Human Services (HHS). The...more

HHS Poised For Round Two Of Orphan Drug Fight

HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

Purgation Case Still Held Up

Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc. Case Number: 1:12-cv-06851-AJN (Dkt. 69) - Judge Nathan approved the parties’ proposal to maintain the case on administrative hold pending...more

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

No Judicial Review of FTC Jurisdiction until the Agency Takes a Final Action

Companies that handle personal data may need to litigate an FTC enforcement action to its conclusion before a court will review the Commission's jurisdiction to commence the enforcement action in the first place....more

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