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    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    FDA Approves US' First Biosimilar Product, but Regulatory Questions Remain

    The US Food and Drug Administration (FDA) has announced the landmark approval of the US' first biosimilar product, Sandoz' Zarxio (filgrastim-sndz), a drug biologically similar to Amgen's Neupogen. The product is the first to be approved under the 351(k) biosimilar pathway, which was first established under the Patient Protection and Affordable Care Act —Obamacare—in 2010. The approval of Zarxio, which is marketed in several other markets under the brand name Zarzio,...
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    Good News for FDA: Both Sides of the Political Aisle Like (and Dislike) it Equally

    The US Food and Drug Administration (FDA) is an agency which often courts controversy. It's blamed when drugs are approved too quickly and are later found to be unsafe; it's blamed when the public believes it's approving drugs too slowly, and it regularly finds itself in the center of political battles between opposing political parties. But according to a new survey by the polling group Nielsen, the agency must be an equal opportunity offender, because it attracts fa...
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    Among Global Drug Regulators, FDA Still the Best, But Others Are Catching up—Fast

    Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS). Background: Study CIRS' analysis looked at new drug approval decisions made over the past decade by six regulators: The US Food and Drug Administration (FDA) The European Medicines Agency (EMA) Japan's Pharmaceutical and Medica...
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    Making Changes to an Already-Approved Drug? FDA's New Guidance Wants to Help

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding how manufacturers of pharmaceutical products can make changes to their manufacturing equipment under FDA's scale-up and post-approval changes (SUPAC) requirements. Background After a pharmaceutical product is approved, its sponsor and manufacturer must work to meet ever-changing manufacturing standards, as well as demand for the drug. Though the drug product itself is still ap...
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    How Many Drug Companies Manage to Get Two New Drugs Approved by FDA? Not Many

    The development of a new pharmaceutical or biopharmaceutical product is a notoriously difficult process. According to industry data compiled by the Tufts Center for the Study of Drug Development, only about one in 10 drugs entering into Phase I clinical trials will ever be approved by the US Food and Drug Administration (FDA)—and those are just the companies whose drugs actually made it to the clinical development stage.  Getting a drug approved, in other words, can feel ...
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    Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster

    A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...
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    FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions

    On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from FDA are eligible for varying degrees of market- (rather than patent-) based exclusivity. For New Chemical Entities (NCEs), that means five years of protection during which time FD...
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    FDA Finalizes Guidance Aimed at Accelerating Approval for Some Breast Cancer Treatments

    A new final guidance document issued by the US Food and Drug Administration (FDA) outlines the processes by which the regulator will accept surrogate endpoints to support the accelerated approval of treatments intended for high-risk early-stage breast cancer. Background Under normal circumstances, FDA requires "substantial evidence"—generally two Phase III clinical trials—indicating that a product is safe and effective at treating, preventing or curing a given condition...
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    Public View of FDA Continues to Improve in New Poll

    More than half of the US public believes that the US Food and Drug Administration (FDA) is doing a good or excellent job, according to a recent survey sponsored by the pro-regulation group Coalition for Sensible Safeguards. The survey, based on a nationwide survey in July 2014 of 700 likely voters from around the country, quizzed respondents on their views of the US government and its many regulatory agencies. Respondents were relatively split on their view of the fe...
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    Flip a Coin: FDA Approves Kidney Diagnostic With 50% False Positive Results

    Risk and benefit are nothing if not relative concepts. A product can have a laundry list of dangerous side effects, but so long as it treats an even more dangerous indication, it can still be approved by regulators. Conversely, a product may present no side effects whatsoever, but if it lacks efficacy, it might still be rejected by regulators. The very heart of the regulatory process is determining which products ought to be approved, and which ones don't quite pass must...
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    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...