Science, Computers & Technology Administrative Agency Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads,...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

OECD Finds Standard Test Guidelines for Normal Chemical Substances Are in Most Part Suitable for Nanomaterials

The Organization for Economic Cooperation and Development (OECD) issued a June 9, 2015, press release entitled “OECD chemical studies show way forward for nanomaterial safety.” The press release states...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

FDA Committee to Continue Considering Drug Compounding Issues

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access...more

District Court Decision Opens Door to Five-Year NCE Exclusivity for Single Components of Previously FDA-Approved Multi-Component...

On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...more

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...more

Long-Term Care Legislation in Florida - Regulatory Compliance Impacts Retirement Communities, ALFs and Nursing Homes

Long-term care companies in Florida need to dust off their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015. If they are signed by...more

HHS Revises, Delays Medicare Enrollment Requirements for Part D Prescriptions

The Affordable Care Act authorized the Department of Health and Human Services (HHS) to require a physician, dentist or other healthcare provider to be enrolled in the Medicare program before they can issue a prescription...more

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

China FDA Releases Guideline for Medical Device Registration Studies

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

Congress Could Be Coming For Dietary Supplements Soon

The next chapter in the saga of New York State Attorney General Eric T. Schneiderman's investigation of the dietary supplements industry may take place on Capitol Hill. On April 2, Schneiderman and the state attorneys general...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

Comingling of employee and patient data compromises employer’s HIPAA defense to employee’s claim of discharge for union activity

An administrative law judge (ALJ) of the National Labor Relations Board has concluded that a health care employer’s use of its medical records software to store employee contact information allowed an employee to access that...more

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out...more

FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released a draft question-and-answer guidance document, titled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” The...more

772 Results
|
View per page
Page: of 31

Follow Science, Computers & Technology Updates on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×