Administrative Agency Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

BRAG® Petitions EPA for Biodiesel Products CDR Exemptions Already Granted to Petroleum Products

On October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted petitions to the U.S. Environmental Protection Agency (EPA) requesting that biodiesel fuel manufacturers be granted the same Chemical...more

How to Respond to FOIA Requests For Overall Teacher Summative Ratings?

LR-hands-over-laptopkeysIt has come to our attention that certain school districts in Connecticut have already received requests under the Freedom of Information Act [“FOIA”] for access to overall district and school level...more

For Whom the Whistle Blows

In This Issue: - Applicability and Protected Activity - Procedure Governing Section 402 Claims - Five Steps to Compliance - For More Information - Excerpt from Applicability and Protected...more

FDA Flunks Data Security Exam

Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more

FDA Issues Cybersecurity Guidelines - Manufacturers of Medical Devices Encouraged to Develop Cybersecurity Controls

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or...more

FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions - Restrictions Loosened but Exemption Remains Narrow

On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration...more

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Work Plan Signals Expanded Calif. Green Chemistry Program

As part of its Safer Consumer Products Regulation (SCPR) under California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC) on September 13, 2014 issued its Draft Priority Product Three-Year Work...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and...more

Health Alert (Australia) - October 20, 2014

In This Issue: Judgements, Legislation, and Reports. Excerpt from Judgments: Commonwealth - 15 October 2014 - Gray v Richards [2014] HCA 40 - In 2003, a 10-year-old girl...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

Wrap-Up of Federal and State Chemical Regulatory Developments, 10/14

EPA Schedules SAP Meeting On Endocrine Activity: On September 16, 2014, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled a four-day meeting of the Federal Insecticide, Fungicide, and Rodenticide...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

Patent Office Extends AFCP 2.0 and QPIDS Pilot Programs to September 2015

The United States Patent and Trademark Office (USPTO) just announced it has extended the After Final Consideration Pilot program (AFCP 2.0) and the Quick Path Information Disclosure Statement program (QPIDS), which are now...more

Phrma Challenges HRSA Interpretative Rule On Orphan Drugs In The 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive...more

IP Newsflash - October 2014 #2

Patents to a “Specific Technological Process” Fall on the Pleadings as Abstract Ideas - On September 22, 2014, Judge George H. Wu (C.D. Cal.) ruled on the pleadings that two Planet Blue patents relating to “the idea of...more

ALJ Denies LabMD’s Motion for Sanctions Against the FTC

Although the litigation between LabMD and the Federal Trade Commission (FTC) continues in the Eleventh Circuit, an administrative law judge has resolved one battle between the two entities. Chief Administrative Law Judge D....more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

Blog: Sunshine Act Media Coverage and CMS’s Response Today

The Open Payments database has been live for a week now. There has been media coverage, but most has not been the type that many expected. The coverage to date has largely centered on the significant challenges associated...more

Broad Language In Specification Can Provide Written Description Support

ScriptPro, LLC v. Innovation Associates, Inc. - In reviving a patent owner’s patent infringement lawsuit, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s summary judgment that a patent was...more

IP Newsflash - October 2014

Federal Circuit Affirms Inequitable Conduct Based On “Intentionally Selective” Disclosure - On September 26, 2014, a divided Federal Circuit panel affirmed the unenforceability of three American Calcar patents,...more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

1,734 Results
|
View per page
Page: of 70

Follow Administrative Agency Updates on: