Search Results for Approvals

Showing 1 – 25  of 72

EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals By Zachary Brennan - Published 13 October 2017

As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: cancer drug approvals, QoL, survival benefit

Another Record Year for US Generic Drug Approvals in 2017 By Zachary Brennan - Published 05 October 2017

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report.

Categories: News, US, CDER, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug approvals, GDUFA, 2017 generic drug approvals

CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway By Zachary Brennan - Published 27 September 2017

Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office."

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: postapproval, 510(k) pathway, medical device approvals, total product life cycle super office

Generic Drugs in 2017: FDA on Track for Most Approvals Ever By Zachary Brennan - Published 08 August 2017

Ten months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record-setting year for abbreviated new drug application (ANDA) approvals from the last year.

Categories: News, US, FDA, Generic drugs, Government affairs, Submission and registration

Tags: generic drug approvals, ANDA approvals

FDA Speeding Generic Drug Approvals: Not Just Lip Service By Zachary Brennan - Published 10 July 2017

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: FDA generic drug approvals, GDUFA, ANDA approvals

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

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

Tags: Keytruda, Merck, biomarkers, oncology approvals

FDA Signs Off on New Device to Treat Esophageal Birth Defect in Babies By Zachary Brennan - Published 12 May 2017

The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in their esophagus.

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

Tags: humanitarian device exemption, FDA device approvals

CDRH Plots Path to New 'Progressive' Approvals for Some Devices By Zachary Brennan - Published 03 May 2017

With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: NEST, MDUFA IV, progressive approvals, breakthrough devices

Fast Start for FDA Drug Approvals in 2017 By Michael Mezher - Published 12 April 2017

The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Approvals, New Molecular Entities, Biologics License Applications

Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017) By Nick Paul Taylor - Published 28 March 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Asia regulatory roundup, fast-track approvals, combination products, antibiotic resistance

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

FDA Continues to Reduce Generic Drug Backlog By Zachary Brennan - Published 22 February 2017

The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700.

Categories: News, US, FDA, Crisis management, Generic drugs, Government affairs

Tags: ANDA approvals, generic drug backlog, generic drug dashboard

FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue By Zachary Brennan - Published 21 February 2017

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: oncology, Pazdur, Oncology Center of Excellence, FDA cancer drug approvals

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

Updated: FDA and EMA in 2016: A Look at the Numbers By Michael Mezher - Published 19 January 2017

The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: New active substances, New molecular entity, Approvals

FDA’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions By Zachary Brennan - Published 18 January 2017

The US Food and Drug Administration (FDA) late Tuesday approved a generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) to help treat a sleep disorder but at least one investment analyst thinks the move could lead to a slippery slope of companies adding drug-drug interaction (DDI) patents and using them to keep generics from entering the market.

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

Tags: Jazz Pharmaceuticals, Xyrem, generic approvals

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 Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals By Zachary Brennan - Published 08 November 2016

The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PhRMA, citizen petitions, generic drug approvals

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

Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers By Zachary Brennan - Published 01 November 2016

As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down.

Categories: News, US, FDA, Generic drugs, Government affairs

Tags: generic drug approvals, drug prices, high drug prices, ANDA approvals, generic drug backlog, FDA backlog

FY 2016 Generic Approvals by FDA: A New Record Under GDUFA By Zachary Brennan - Published 12 October 2016

The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: OGD, ANDA approvals, FDA approvals of generic drugs

Almost 90% of PMA Applicants Received Major Deficiency Letter on First FDA Review Cycle in 2016 By Zachary Brennan - Published 09 September 2016

New data from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) show that through the first six months of 2016, 89% of premarket approval applications (PMAs) received a major deficiency letter in the first review cycle.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, PMA approvals, major deficiency letters

FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment By Zachary Brennan - Published 04 August 2016

The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Tamiflu, Roche, Natco, ANDA approvals

FDA Rejects Highest Number of Monthly Generic Drug Applications Ever By Zachary Brennan - Published 08 June 2016

The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Quality

Tags: ANDA approvals, complete response letters, CRLs, generic drug applications

CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices By Zachary Brennan - Published 31 May 2016

A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program.

Categories: News, US, CDRH, Clinical, Government affairs, Medical Devices, Postmarket surveillance

Tags: expedited device approvals, EAP, breakthrough devices