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. Over the past year, CDRH has made 29 decisions on requests for designation into its voluntary Expedited Access Pathway (EAP) program, an...

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. The latest data, covering the period from January through March 2016, shows that the number of ANDAs pending filing review has declined from 211 ANDAs as of 1 Janua...

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. Background Article 58 of Regulation (EC) No 726/2004, introduced first in 2004, allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with ...

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). More than 700 generic drugs were approved and tentatively approved in 2015, which was the highest figure ever; and in December, FDA granted the highest number of approvals and tentative approvals in...

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). As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, ...

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. Since 2012, when the first GDUFA was created to provide FDA with indu...

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. The total of 45 approvals was well ahead of FDA’s average of about 28 novel approvals between 2006 and 2014, and 36% of those new approvals were for first-in-class drugs while almost half (47%) were to treat rare diseases, or ailments that impact 200,000 or...

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. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...

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. Mr. Shapiro comments on some of the arguments made in our investigation o...

Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs). The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study...

With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can not only negotiate three new user fee agreements but fill an enormous number of staff vacancies. CDER Director Janet Woodcock, speaking Monday at the FDA/CMS Summit in Washington, DC, outlined 2015’s achievements and a number of the agency’s top priorities for ...

The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...