David Hoffmeister

David Hoffmeister

Wilson Sonsini Goodrich & Rosati

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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

6/24/2015 - Diagnostic Tests DOJ Emerging Growth Companies Enforcement Actions Equity Financing False Claims Act FDA Healthcare Human Genome Project IPO Life Sciences Manufacturers Medical Devices Myriad Patent Infringement Patents Personalized Medicine Venture Capital

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

6/3/2015 - ANDA FDA Generic Drugs Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Product Exclusivity

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

4/24/2015 - FDA FDCA Manufacturers Pending Legislation Personal Care Products Registration Requirement

Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers

On March 19, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services issued their joint annual report on health care fraud and abuse control. The annual report states that during fiscal year...more

4/6/2015 - Annual Reports DOJ Enforcement Statistics Healthcare Fraud HHS Medical Devices

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

3/17/2015 - Biologics Clinical Trials Drug Manufacturers FDA Informed Consent Medical Devices Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

Highlights and Commentary from the FDA's Public Workshop on Proposed Framework for Regulatory Oversight of Laboratory Developed...

On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more

1/16/2015 - FDA Laboratory Developed Tests Proposed Regulation Regulatory Agenda

FDA Issues Notice to Congress of Its Intent to Comprehensively Regulate Laboratory Developed Tests (LDTs)

On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more

8/7/2014 - Clinical Laboratories Enforcement Guidance FDA Laboratory Developed Tests Medical Devices

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...more

5/1/2014 - Digital Health Healthcare IPO Patents SBIRs Startups Venture Funding

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

2/27/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Prescription Drugs

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

10/4/2013 - Biotechnology FDA Life Sciences Medical Devices Mobile Apps Patent Applications Patents Pharmaceutical Telemedicine USPTO Venture Capital

The Life Sciences Report - Spring 2013

In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more

6/12/2013 - America Invents Act Civil Monetary Penalty CMS Final Rules Mayo Foundation for Medical Ed Mayo v. Prometheus Patent Reform Patents Sunshine Act Venture Capital

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