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Medical Devices Pharmaceutical Industry New Legislation

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

Goodwin

Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to...

Goodwin on

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more

Akerman LLP - Health Law Rx

New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of...more

Robinson+Cole Health Law Diagnosis

Connecticut Legislature Extends Immunity for Emergency Assistance by Health Care Professionals to Cover Malfunctioning Automatic...

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-113 “An Act Concerning the Use of Automatic External Defibrillators” (PA 19-113). This law takes effect October 1, 2019....more

Robinson+Cole Health Law Diagnosis

Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19). PA 19-19 went into effect on the same date....more

Hogan Lovells

New Belgian legislation on the distribution of medical devices

Hogan Lovells on

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

Troutman Pepper

Future Expansion of Sunshine Act Reporting to Cover Additional Prescribers

Troutman Pepper on

On October 24, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)....more

Hogan Lovells

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

Smart & Biggar

New challenges and opportunities for pharmaceutical trademarks in Canada

Smart & Biggar on

In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. This article will canvas the current issues as well as the important changes...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Stinson - Benefits Notes Blog

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

K&L Gates LLP on

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

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