Search Results for Regenerative medicine

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FDA Unveils New Regenerative Medicine Framework By Zachary Brennan - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday launched a new policy framework for regenerative medicine, building off a previous framework from 2005, as part of efforts to bring new cell, stem cell and tissue products to patients as efficiently as possible while managing the proliferation of unscrupulous actors hawking unproven therapies.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regenerative medicine, RMAT, FDA guidance

Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies Published 08 September 2017

In this interview with Regulatory Focus, Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies.

Categories: Features, US, FDA, Biologics and biotechnology, Human cell and tissue, Reimbursement

Tags: Regenerative Medicine, ARM, Michael Werner, Ted Slocomb

FDA to Unveil New Regulatory Framework for Stem Cell Therapies By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration's (FDA) Commissioner Scott Gottlieb said Monday the agency this fall will advance a new framework to regulate stem cell therapies.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: stem cell therapy, FDA on regenerative medicine, DTC stem cell clinics

Conditional Approvals for Early Access to New Medications By Sharry Arora - Published 31 May 2017

This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

Categories: Features, Japan, Europe, US, EMA, FDA, ICH, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Conditional approval, Regenerative medicine

CBER Director Focuses on Flexibility to Advance Regenerative Medicines By Michael Mezher - Published 08 May 2017

Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday said his office is equipped to support the development of cutting edge treatments, such as cell and gene therapies.

Categories: News, US, CBER, Biologics and biotechnology, Human cell and tissue, Regulatory strategy

Tags: Regenerative Medicine, Cell and Gene Therapy, Advanced Therapies, RMAT Designation

Humacyte Receives First of FDA’s Regenerative Medicine Designations By Zachary Brennan - Published 20 March 2017

The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: RMAT designation, regenerative medicine, 21st Century Cures

Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns By Zachary Brennan - Published 07 December 2016

The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Cures, 21st Century Cures, regenerative medicine, FDA, safety and efficacy

Senate Bill Seeks to Create Standards Body for Regenerative Medicine By Michael Mezher - Published 15 January 2016

Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Human cell and tissue

Tags: Gene therapy, Cell therapy, Regenerative medicine, Advances therapies, Senator Tammy Baldwin, Michael Werner

Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine By Alexander Gaffney, RAC - Published 30 April 2014

Categories: US, FDA

Tags: Regenerative Medicine, Cures Acceleration Network, CAN, Legislation, Latest News, regulatory science, Bill