Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 22 July 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.
Bioequivalence refers to the "absence of a significant difference" between the bioavailability—specifically the extent and rate of absorption—of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the same dose and under the same conditions. "The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug," FDA explains on its website.
Drugs that are deemed to be bioequivalent are, for regulatory purposes, essentially the same.
But in practical terms, generic drug companies are often most concerned with two things:
In order to facilitate that process, FDA regularly publishes what it calls "bioequivalence recommendations for specific products," which contains more than 1,000 recommendations.
These recommendations most often contain the recommended number of bioequivalence studies that must be conducted in order to obtain approval, as well as the general designs of the study, acceptable parameters of bioequivalency, and any other considerations sponsors must keep in mind.
On 22 July 2014, FDA released 37 new BE standards, including ones for generic versions of Janssen's Invokana, Pfizer's Xalkori, Biogen Idec's Tecfidera, and AstraZeneca's Nexium 24HR.
Those guidances are still in draft form. FDA also said it had revised 12 other BE guidances.
The documents are set to be posted on FDA's website on 23 July 2014, and will be available here.
Federal Register Notice
Tags: BE, Bioequivalence, Bioequivalence Standards
Regulatory Focus newsletters
All the biggest regulatory news and happenings.