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    Updated: FDA and EMA in 2016: A Look at the Numbers

    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. In fact, both regulators saw the lowest number of new drugs given a positive review in their respective jurisdictions in years. For EMA, the number represents the fewest NASs recommended in a...
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    FDA’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions

    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. In addition to granting approval to the generic, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for ...
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    New FDA Drug Approvals: Breaking Down the Numbers

    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. And with only 18 FDA decisions on new drugs expected in 2017, according to BioPharma Catalyst , the number of FDA approvals may continue to decline to a level the industry has not seen since 2007, when 18 new molecular entities (NMEs) and new biologic license applications (BLAs) were approved. But as John ...
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    FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals

    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. The final rule, which is effective 9 January 2017, implements section 505(q) of the Federal Food, Drug & Cosmetics Act (FD&C Act), which governs the manner in which FDA ...
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    FDA’s Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift

    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. “There are fewer applications in front of us to act upon,” Jenkins said, noting that although he cannot discuss in...
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    Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers

    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. But is the generic drug backlog, also known as the abbreviated new drug application (ANDA) backlog, that big of a problem? Or is confusion over what exactly this backlog means and how long it takes FDA to approve gener...
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    FY 2016 Generic Approvals by FDA: A New Record Under GDUFA

    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 . But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year....
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    FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment

    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. Tamiflu, first approved in 1999, earned Roche more than $3 billion back in 2009 and more than $400 million in 2015, though its effectiveness was questioned back in 2014. Now, India-based Natco and ...
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    FDA Rejects Highest Number of Monthly Generic Drug Applications Ever

    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. In the latest release of raw data on Tuesday of approvals and complete response letters (CRLs), also known as rejections, for ANDAs, FDA said that in the month ending 16 April 2016, it...
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    CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices

    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...
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    FDA Slowly Chips Away at ANDA Backlog

    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...
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    Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries

    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 ...