Regulatory NewsRegulatory News
FDA withdraws more than 200 ANDAs over unsubmitted annual reports
Posted 21 October 2021 By Michael Mezher
Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday s...
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Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug
Posted 21 October 2021 By Michael Mezher
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Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations
Posted 20 October 2021 By Michael Mezher
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Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds
Posted 19 October 2021 By Michael Mezher
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Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children
Posted 18 October 2021 By Michael Mezher
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FDA officials tout progress and achievements in advanced manufacturing
Posted 15 October 2021 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in th...
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CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz
Posted 15 October 2021 By Michael Mezher
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.
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Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug
Posted 15 October 2021 By Michael Mezher
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Wednesday, 17 November 2021 (9:00 - 5:30PM) 6.0 RAC Credits An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is tailored for new to intermediate level professionals and those preparing for the RAC Drugs examination.
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Expanded and updated risk management information on healthcare products around the world.
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Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
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Complete WHO Guidance Documentation Bundle
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A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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Regulatory Affairs Certificate: Pharmaceuticals
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The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five of the elective courses outlined below.
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If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.
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This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
     
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