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    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    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...
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    Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

    Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...
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    FDA Seeks Participants for Emerging Pharma Manufacturing Tech Program

    The US Food and Drug Administration (FDA) is looking for companies to participate in a program that will review the latest in cutting-edge pharmaceutical manufacturing technology. For companies submitting an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the Center for Drug Evaluation and Research (CDER) with the use of such emerging manufac...
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    New Law Redefines When Controlled Substances are Officially Approved

    Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved. The new law, known as the Improving Regulatory Transparency for New Medical Therapies Act, sets new deadlines for the US Drug Enforcement Administration (DEA) to schedule controlled substances, like opioids and other drugs that have the potential to be abu...
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    FDA Bans Imports From Major Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US. Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market , including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and over...
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    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
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    Asia Regulatory Roundup: India Prepares to Invest in State Drug Regulators (22 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Sets Terms for State Regulatory Investment Plan The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals. Ministry of Health officials ha...
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    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
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    Canada Proposes New Drug Enforcement Measures, Including Scheduling

    Canada's Minister of Health Rona Ambrose has just announced a series of amendments to the country's Controlled Drugs and Substances Act (CDSA) intended to curb illegal drug manufacturing and use. Proposed Changes The amendments are part of The Protection of Communities from the Evolving Dangerous Drug Trade Act , which increase the government's ability to police and regulate active substances, both legal and illegal. While the amendments are geared toward combating...
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    RAPS Mid-Atlantic Career Day Draws Nearly 100 to Learn, Network

    Earlier this month, nearly 100 regulatory professionals, career changers, students and others gathered at the Montgomery County (MD) campus of Johns Hopkins University to learn, network and perhaps take the next steps in their regulatory careers. This was the second year for this regional career event. It was organized by RAPS DC/Baltimore Chapter Co-Chairs Nancy Singer (pictured), RAC, FRAPS, JD, president, Compliance Alliance LLC; and Daniela Drago, PhD, assis...
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    FDA Releases Guidance for Clinical Trial Sponsor-Investigators

    New guidance issued by the US Food and Drug Administration (FDA) instructs clinical trial sponsor-investigators on how to complete an investigational new drug application (IND)—an application used by FDA to approve the start of a new trial. As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators , "Sponsor-investigators seeking to do clinical research often do not have the reg...
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    EMA to Monitor Select Medical Literature for Drug Side Effects

    The European Medicines Agency (EMA) is launching a new initiative to monitor selected medical literature to proactively identify suspected adverse drug reactions (ADRs) for some 400 active substances. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected ADRs. This informati...