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    Drug Safety Reports Still Uninformative, FDA Officials Say

    Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article. Sponsors are required to compile all adverse events for drugs they are studying in annual safety reports. If an adverse event is serious, unexpected or suspected to be caused by the drug being studied, sponsors are required to submit an expedited report to FDA within 15 days ...
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    Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US

    As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US. Because FDA is classified as a stringent regulatory authority, the agency’s review of drugs and devices...
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    EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

    The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns. The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU. Following consideration of the inspectio...
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    FDA Review Times Steadily Decreasing, Report Finds

    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. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...
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    Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms

    Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun. And although that love is sure to be a good sign for companies looking to make hefty profits off of the vouchers on the open market (selling for upwards of $350 million), it’s a bad sign for the US Food and Drug Administration (...
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    FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products

    The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one manufacturer. The change, which would effectively speed up the review of so-called "sole-source" generic drugs could increase competition, help with drug shortages and may even drive down the cost of expensive generics that have no competition. The change came in the form of an upd...
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    Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills

    The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program. The advancement of the bill sponsored by Sen. Bob Casey (D-PA) to extend the pediatric PRV program comes as the US Food and Drug Administration (FDA) told the Government Accountability Office ...
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    More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program

    In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics. Sen. Susan Collins’ (R-ME) bill, known as “A bill to increase competition in the pharmaceutical industry,” would amend the Federal Food, Drug, and Cosmetic Act to require the US Food and Drug A...
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    FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness

    The US Government Accountability Office (GAO) said Wednesday in a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments affecting fewer than 200,000 people, more than half o...
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    Asia Regulatory Roundup: CFDA Builds Priority Review Pathway for Drug Approvals (1 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Creates Priority Review Pathway for Cancer, Rare Disease Drugs The China Food and Drug Administration (CFDA) is creating a priority review pathway to cut the time it takes for some drugs to come to market. CFDA is aiming the initiative at products to treat certain significant illnesses and those that use advanced technology to deliver clear therapeutic benefits. In th...
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    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...
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    Sanofi Redeems $245M Priority Review Voucher for Type 2 Diabetes Treatment

    The US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Sanofi’s investigational type 2 diabetes treatment on Monday and granted the use of another Priority Review Voucher (PRV), which speeds up FDA’s decision by four months. In redeeming the voucher, Sanofi had to pay a $2.7 million fee in addition to the standard new drug filing fee of $2.4 million. Retrophin sold the PRV to Sanofi last May for one of the highest amounts eve...