Search Results for Approvals

Showing 1 – 25  of 64

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

FDA Slowly Chips Away at ANDA Backlog By Zachary Brennan - Published 02 May 2016

Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday.

Categories: News, US, CDER, Compliance, Generic drugs, Due Diligence, Government affairs, Submission and registration

Tags: ANDA backlog, generic drug applications, FDA generic approvals

Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries By Zachary Brennan - Published 26 April 2016

Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program.

Categories: News, Africa, Asia, Europe, Middle East, Oceania, EC, EMA, WHO, Biologics and biotechnology, Distribution, Drugs, Ethics, Government affairs, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Article 58, LMIC medicines, vaccines, tuberculosis, drug approvals, NRAs

Generic Drug Approvals Hit New Record in 2015, FDA Report Shows By Zachary Brennan - Published 13 April 2016

The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD).

Tags: generic drug approvals, ANDA backlog, OGD report

WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries By Zachary Brennan - Published 19 February 2016

A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine).

Categories: News, Africa, WHO, Crisis management, Drugs, Government affairs, Regulatory strategy, Submission and registration

Tags: WHO, Johnson & Johnson, Africa drug approvals, African drug regulators

FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II By Zachary Brennan - Published 28 January 2016

Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told Senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Due Diligence, Government affairs, Manufacturing, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, generic drugs, Janet Woodcock, Senate HELP, ANDA approvals

First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA By Zachary Brennan - Published 26 January 2016

Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options.

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

Tags: FDA approvals, rare disease, first-in-class new drugs, accelerated approval, breakthrough therapy

EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record By Michael Mezher - Published 12 January 2016

In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014, granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17.

Categories: News, Europe, EMA, CDER, Biologics and biotechnology, Drugs, Orphan products, Submission and registration

Tags: New active substance, new chemical entity, 2015 approvals, Marketing authorization

Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little By Vinay Prasad MD, MPH - Published 17 December 2015

This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University.

Categories: News, US, FDA, Clinical, Crisis management, Drugs, Government affairs

Tags: cancer drugs, oncology drug pricing, JAMA, cancer drug approvals