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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

From 2020, Russia will introduce a compulsory system for tracking pharmaceuticals from manufacturer to end user

by Dentons on

On December 29, 2017, the RF President signed Federal Law No. 425-FZ of December 28, 2017 On Amendments to the Federal Law On the Circulation of Pharmaceuticals ("Law 425-FZ"). Under Law 425-FZ, in order to ensure effective...more

FDA, FTC Try to Stop Opioid Cessation Products

Marketers of opioid cessation products received warning letters from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), cautioning them about unproven claims for the treatment of opioid addiction...more

THE LATEST: Divestitures of Complex Pipeline Pharmaceutical Products off the Table at the FTC

by McDermott Will & Emery on

WHAT HAPPENED: - Bruce Hoffman, acting director of the Bureau of Competition at the Federal Trade Commission (FTC), announced that the FTC will no longer accept divestitures of inhalant and injectable pipeline drugs in...more

Claims for Cancer Products Make FTC Sick

The Federal Trade Commission (FTC) reached a deal with a company and its CEO over false and unsupported claims that its products could help patients with the side effects of cancer....more

AGG Food and Drug Newsletter - January 2018

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The State AG Report Weekly Update

by Cozen O'Connor on

Cozen in the News- JB Kelly Interviewed by Natural Products Insider on FTC Guidance for Multi-Level Marketers- JB Kelly, member of Cozen O’Connor’s State Attorneys General practice, was interviewed by Natural Products...more

Potential Impacts on Telehealth From Net Neutrality Repeal

On December 14, 2017, the Federal Communications Commission (FCC) passed the Restoring Internet Freedom Order (RIFO), repealing the FCC’s 2015 “net neutrality” rules and shifting the responsibility for regulating the conduct...more

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

by Mintz Levin on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

ICYMI: PrivSec’s Weekly News Picks

by Davis Wright Tremaine LLP on

Tech Republic reports that “the executive order may help bring internet to previously hard to reach areas, something several ISPs have been working towards.” “A more connected country”, author Olivia Krauth reports, “could...more

French Competition Authority Fines a Pharmaceutical Laboratory EUR 25 Million for Anti-Generic Practices

by McDermott Will & Emery on

On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version of Durogesic, and for hindering its...more

FDA Guidance on Decision Support Software: Implications for Industry

by Epstein Becker & Green on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

China FDA Solicits Comments on Conditional Approvals for New Drugs and Compassionate Use of Investigational Drugs

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed two draft circulars for public comments, namely (a) the Technical Guidelines for Conditional Approvals for Urgently Needed Drugs (“Draft Conditional Approvals...more

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

by Latham & Watkins LLP on

New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more

Why worry about gung-ho approvals for medical devices? FDA’s own record

The Food and Drug Administration has closed out the year by issuing a new white paper reaffirming the agency’s three-year-old warning to surgeons and women to avoid in general the use of a surgical device called a morcellator...more

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Pfizer Accuses J&J of Anticompetitive Business Practices over Remicade Biosimilar

by Knobbe Martens on

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, Celltrion’s partner Pfizer has filed a suit against...more

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

by Dorsey & Whitney LLP on

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

FDA Releases Biosimilars Educational Materials

by Goodwin on

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that...more

Health Update - October 2017

A New Look at Digital Health Business Models - Editor’s Note: The Commonwealth Fund is developing an innovative digital health advisor (DHA)—an integrated suite of digital services that would provide consumers with health...more

China FDA’s Pharmaceutical Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) published its proposed amendment of the Drug Administration Law (DAL) and the Drug Registration Rules (DRR) for public comments. This Alert summarizes the key changes....more

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