Search Results for new drug approvals

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Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High By Zachary Brennan - Published 21 December 2017

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the highest number of NMEs approved in any year except 1996.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: new drug approvals, new molecular entities, Addyi,

505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times By Zachary Brennan - Published 09 March 2017

With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: 505(b)(2) pathway, new drug approvals, Tufts, approval times

New FDA Drug Approvals: Breaking Down the Numbers By Zachary Brennan - Published 04 January 2017

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: new drug approvals, pharmaceutical approvals, FDA approval

FDA’s Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift By Zachary Brennan - Published 04 November 2016

With less than half the number of new drugs approved in 2016 (19 so far) when compared to 2015 (45 total), John Jenkins, director of the US Food and Drug Administration’s (FDA) Office of New Drugs, told attendees Friday at a Prevision Policy conference in Washington, DC, that the decline has not been due to a shift in the agency’s standards or policies.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: new drug approvals, OND, John Jenkins, complete response letters

Japan Edges out FDA for Fastest Approvals By Michael Mezher - Published 31 July 2015

In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs).

Categories: News, Japan, Europe, US, EMA, FDA, MHLW, PMDA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: New drug approvals, New active substance, NAS, Centre for Innovation in Regulatory Science, CIRS, ICH, Orphan drugs, Expedited review, Priority Review

China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval By Ji Wang, Jun Zuo, Hua Zhang, Thuy Dang and Joseph Scheeren, PharmD - Published 23 April 2015

A review of the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014, providing insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China.

Categories: Features, China, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: China, CFDA, China Food and Drug Administration, clinical trials, new drug approvals, new biologics approvals, Chinese patients, international multicenter trials, IMCT, Asia Pacific

Among Global Drug Regulators, FDA Still the Best, But Others Are Catching up—Fast By Alexander Gaffney, RAC - Published 14 January 2015

Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS).

Categories: News, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Biologics and biotechnology, Drugs, Submission and registration

Tags: CIRS, New Drug Approvals, Average Approval Times, FDA Average Drug Approval, EMA Average Drug Approval

FDA Touts Strong Drug Approval Performance in 2014 By Alexander Gaffney, RAC - Published 11 December 2014

The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals."

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: FDA New Drug Approvals, 2014 New Drug Approvals, FDA NME Approvals