Administrative Agency Science, Computers & Technology

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FDA Draft Guidance Clarifies Criteria and Process for Obtaining Rare Pediatric Disease Priority Review Vouchers

On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more

Lawmakers Seek Details On Consumer Data Breaches From Financial Institutions

On November 18, 2014, several major financial institutions received requests from lawmakers for detailed information about recent data breaches and for briefings from their corporate data security officials. The lawmakers...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

European Companies Appeal ECHA Titanium Dioxide Decision

The European Chemicals Agency (ECHA) published on November 3, 2014, an announcement of appeal of a June 17, 2014, contested decision following a compliance check of the Registration, Evaluation, Authorization and Restriction...more

As Bitcoin Gains Momentum, Focus on Regulation Increases

The virtual currency market has emerged in the United Arab Emirates with Dubai’s first Bitcoin ATM introduced in April 2014. Middle East entrepreneurs have begun launching Bitcoin payment products and SMEs are beginning to...more

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more

Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

HRSA Withdraws 340B Program Proposed Rule

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the...more

FDA Posts New Materials on Proposed Laboratory Developed Test (LDT) Regulatory Framework

On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more

HRSA Abandons Plans for “Mega-Rule” for 340B Drug Pricing Program

Based on a notice posted on its Office of Pharmacy Affairs (OPA) website, the Health Resources and Services Administration (HRSA) intends to issue in 2015 proposed guidance addressing key policy issues raised by the various...more

The 340B Mega-Reg is Dead

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more

NTSB Says Drones Subject to Federal Aviation Regulations - The Ruling Calls Attention to the Need for New, Sensible Regulations...

The National Transportation Safety Board (NTSB) has overturned an administrative ruling in favor of an aerial photographer, upholding the Federal Aviation Administration's (FAA) determination that unmanned aerial systems...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

Breaking 340B News: HRSA Withdrew its Much-Anticipated 340B Mega-Reg

On Thursday, HRSA formally withdrew its much-anticipated 340B Mega-Reg from the rulemaking process, effectively abandoning its effort to overhaul existing 340B program guidance through new regulations. Commander Krista...more

Nevada Secretary Of State Denies Hacking Claim

Recently, Cytta Corp., a small Nevada corporation, filed this Form 8-K reporting that it had “discovered that it was the victim of an online hacking incident on October 30th, 2014 in that, unauthorized person or persons...more

The New Promotional Rules: “There Are No New Promotional Rules”

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more

OSHA To Provide Enforcement Discretion On June 2015, Deadline For SDS

On October 31, 2014, the Occupational Safety and Health Administration (OSHA) responded to an August 2014 petition from the American Coatings Association (ACA) and other trade associations to extend the June 1, 2015,...more

Same Surgical Procedure Exception under 21 CFR 1271.15(b): FDA Raises More Questions Than it Answers Regarding the Scope of the...

The FDA has released a new draft guidance document for industry entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” (the Guidance Document), which...more

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

PTAB: Claims for Method of Authenticating a Website are Patentable under Alice and Section 101

In a CBM petition filed by petitioners PNC Bank, U.S. Bank, and Bancorp, the petitioners sought review of U.S. Patent No. 7,631,191, which claims a method of authenticating a web page. The petition challenged the validity of...more

Data Privacy And Cybersecurity For Investment Funds

In This Presentation: - WHY IS DATA PRIVACY AND SECURITY IMPORTANT? ..Why is it important to protect data? ..SEC Cybersecurity Risk Alert ..FINRA Scrutiny - BEFORE THE BREACH ...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

FinCEN Continues Scrutiny of Virtual Currency Companies

The Financial Crimes Enforcement Network recently issued two administrative rulings holding that certain virtual currency trading platforms and payment systems were subject to registration as money services businesses....more

FinCEN Rules Proposed Virtual Currency Exchange, Bitcoin Payment System Subject to BSA

On October 27, FinCEN issued two administrative rulings to companies seeking guidance on whether they must register as MSBs and be subject to the required reporting, recordkeeping, and monitoring obligations. In its first...more

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