Search Results for Conditional approval

Showing 1 – 5

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

Global Regulatory Strategy By Prerna Menon - Published 11 October 2016

This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers.

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

Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake

PhRMA: Recommended Language in FDA Accelerated Drug Labeling Guidance Misleading By Alexander Gaffney, RAC - Published 02 June 2014

Pharmaceutical industry trade group PhRMA has come out forcefully against language contained within a draft guidance document issued in March 2014 by the US Food and Drug Administration (FDA), calling the agency's take on labeling drugs granted accelerated approval potentially confusing to patients and undercutting faith in the regulatory system.

Categories: News, US, FDA, Prescription drugs, Labeling

Tags: PhRMA, Guidance, Accelerated Approval, Draft Guidance, Labeling, Conditional Approval

Bill Looks to Establish Provisional Approval Framework for Some Products By Alexander Gaffney - Published 09 August 2012

Categories: FDA

Tags: Partial Approval, Provisional Approval, Fast Track, Conditional Approval, Bilbray, Legislation, House, Latest News, Bill, Congress

Proposed Legislation Would Allow for Conditional Clearance of Medical Devices By Alexander Gaffney - Published 01 June 2012

Tags: Conditional Approval, Braley, Legislation, House, Latest News, Senate, Bill, Congress, Medical Device Patient Safety Act, recalls, medical device