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Designed specifically for the experienced regulatory professional, the RAPS Executive Development program builds key management, business and leadership skills through intense discussions with some of the world’s best business professors in an intimate learning environment at the Kellogg School of Management.
Foster City, CA3/4/2016
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As drug price increases continue to make waves on the national level, Congress is taking the matter into its own hands by requiring generic drugmakers under the Medicaid Drug Rebate Program to pay higher rebates if generic prices rise too quickly.
The US Food and Drug Administration (FDA)'s final guidance issued on Friday will help the generic drug industry prepare for completeness assessments for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA).
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.
The decision to pursue Regulatory Affairs Certification (RAC) is a personal one with many variables to consider—from the amount of regulatory experience you have and the potential value of having the credential to how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account.
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Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. View More
As part of Health Canada’s transparency push, the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016. View More
The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket submissions, as well final guidance from 2011 on applying human factors and usability engineering to medical devices. View More
As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India. View More