Search Results for FDA approval

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FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin By Zachary Brennan - Published 01 December 2017

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology

Tags: Herceptin, biosimilar, FDA approval

FDA Approves 5th Biosimilar, 2nd for Remicade By Zachary Brennan - Published 21 April 2017

The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications.

Categories: News, US, FDA, Biologics and biotechnology

Tags: biosimilar, FDA approval

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

Medical Device Performance Goals: FDA Offers a Quarterly Update By Zachary Brennan - Published 09 December 2016

The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: 510(k), PMA, FDA approval of medical device, devices substantially equivalent

Sarepta Wins Controversial FDA Approval for First DMD Drug By Zachary Brennan - Published 19 September 2016

The US Food and Drug Administration (FDA) on Monday approved Sarepta Therapeutics’ first drug to treat patients with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness in young children.

Categories: News, US, FDA, Drugs

Tags: Sarepta Therapeutics, DMD, eteplirsen, FDA approval of DMD drug

Physicians Lack Understanding of What ‘Breakthrough’ Designation Means, Study Finds By Zachary Brennan - Published 12 April 2016

A US survey of board-certified internists and specialists revealed “substantial deficits in knowledge” of what it means for a drug to be approved by the US Food and Drug Administration (FDA) and approved via the “breakthrough” pathway, according to a research letter published in JAMA on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: breakthrough therapy, breakthrough designation, FDA approval pathways

FDA Review Times Steadily Decreasing, Report Finds By Zachary Brennan - Published 29 March 2016

Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: FDA review times, FDA approval trends, breakthrough designations

Senate Committee Investigates FDA's Compassionate Use Program By Zachary Brennan - Published 22 February 2016

The Senate Committee on Homeland Security and Governmental Affairs late last week sent a letter to US Food and Drug Administration (FDA) Acting Commissioner Stephen Ostroff with new questions on compassionate use, FDA’s approval timelines and helping patients with terminal illnesses.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Due Diligence, Government affairs, Submission and registration

Tags: Senate committee and FDA, FDA approval process, compassionate use

New Law Redefines When Controlled Substances are Officially Approved By Zachary Brennan - Published 30 November 2015

Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: DEA, FDA approval, controlled substances, opioids

Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside? By Zachary Brennan - Published 21 October 2015

In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA, approval, NME, Ostroff, Pfizer, AstraZeneca, Shire

Good News for FDA: Both Sides of the Political Aisle Like (and Dislike) it Equally By Alexander Gaffney, RAC - Published 03 March 2015

The US Food and Drug Administration (FDA) is an agency which often courts controversy. But according to a new survey by the polling group Nielsen, the agency must be an equal opportunity offender, because it attracts fairly uniform—and high levels of—support from Democrats and Republicans alike.

Categories: News, US, FDA

Tags: Poll, FDA Approval Numbers, FDA Favorability

Public View of FDA Continues to Improve in New Poll By Alexander Gaffney, RAC - Published 02 October 2014

More than half of the US public believes that the US Food and Drug Administration (FDA) is doing a good or excellent job, according to a recent survey sponsored by the pro-regulation group Coalition for Sensible Safeguards.

Categories: News, US, FDA

Tags: FDA Approval, FDA Approval Numbers, FDA Approval Poll, Public Approval of Drug Regulation