News & Analysis as of

Medical Devices Drug Approvals

King & Spalding

EU Aims for Ban of PFAS. Now is the Time to Act.

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Earlier this year, the European Chemicals Agency (ECHA) published a proposal for a ban on the production, use and placing on the market (including import) of at least 10,000 per- and polyfluoroalkyl substances (PFAS)....more

King & Spalding

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

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In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

Smart & Biggar

Proposed amendments to Food and Drug Regulations and Medical Devices Regulations would modernize the regulatory system for...

Smart & Biggar on

On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q4 2020

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more

Smart & Biggar

Rx IP Update - January 2019

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IN THIS ISSUE: -Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative - PMPRB News: **PMPRB issues a Notice of Hearing for allegations of excessive...more

Holland & Knight LLP

The Government Shutdown and Its Effects on the FDA

Holland & Knight LLP on

Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Knobbe Martens

First Ever Marijuana-Related Medical Device Approved

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According to PR Newswire, the Israeli Ministry of Health has grated initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel...more

Smart & Biggar

Rx IP Update - December 2017

Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Smart & Biggar

Rx IP Update - May 2017

Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

Foley & Lardner LLP

Trump's Proposed 2018 Budget Will Double FDA User Fees

Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Knobbe Martens

Ingestible e-Pill Approved For Use in Hospitals

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BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

Epstein Becker & Green

FDA Seeks Public Comment on Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved...

Epstein Becker & Green on

On March 3, 2014, the U.S. Food and Drug Administration ("FDA") made available for comment a revised draft of its "Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended...more

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