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241 results found


Keller and Heckman LLP | USA | 24 Oct 2018

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce


Drinker Biddle & Reath LLP | USA | 23 Oct 2018

510(k) Safety and Effectiveness - A Changing Landscape for Punitive Damages?

The Central District of California recently issued an opinion that breathes new life into the argument that the 510(k) substantial equivalence


Stinson LLP | USA | 1 Oct 2018

FDA Draft Guidance and Pilot Program Seek to Expand Device Modifications Appropriate for the Special 510(k) Program

In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a


Seyfarth Shaw LLP | USA | 3 May 2018

NLRB Finds Cocktail Waitress Was Illegally Fired For Voicing Workplace Complaints

On April 26, 2018, in Parkview Lounge, LLC dba Ascent Lounge, 366 NLRB No. 71, the National Labor Relations Board affirmed an NLRB administrative


Fenwick & West LLP | USA | 7 Nov 2017

SEC's Latest Guidance Clarifies Rule 701 Disclosure Delivery Requirements

The U.S. Securities and Exchange Commission (SEC) on November 6, 2017, clarified the requirements for delivering financial and other disclosures to


Harness, Dickey & Pierce, PLC | USA | 29 Sep 2017

Hypothetical Claim in Doctrine of Equivalents Analysis Cannot Narrow Claim Scope

In Jang v. Boston Scientific Corp., 2016-1275, 2016-1575 (September 29, 2017), the Federal Circuit affirmed the district court’s denial of Jang’s


Sheppard Mullin Richter & Hampton LLP | USA | 10 Jul 2017

Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s


Ropes & Gray LLP | USA | 13 Dec 2016

21st Century Cures Act - Provisions Relating to Medical Device Innovation

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of


Katten Muchin Rosenman LLP | USA | 2 Sep 2016

SEC To Approve FINRA and MSRB Pay-To-Play Rules

On August 25, the Securities and Exchange Commission (SEC) issued notices (Notices) to the Financial Industry Regulatory Authority and the Municipal


McDermott Will & Emery | USA | 10 Aug 2016

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff

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