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 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.
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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 10 February 2015 | By Alexander Gaffney, RAC,
New guidance issued by the US Food and Drug Administration (FDA) is intended to make it easier for pharmaceutical companies to develop drugs to treat "complicated" intra-abdominal infections (cIAIs), with a goal of achieving a successful outcome within 28 days of a patient starting treatment.
The final guidance document, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, is an update to a 2012 draft guidance by the same name and meant to answer a common question in drug development: What information would a company need to collect to indicate that its product is safe and effective?
FDA's guidance contains several answers to this question as it relates specifically to cIAIs—a common type of infection which can result in severe sepsis and death.
New drug application sponsors can use data from either a non-inferiority trial—a trial showing a drug is no worse than the next best competitor—or a superiority trial, which indicates that a product is better than the current standard of treatment.
As is standard practice, trials should be randomized, double-blind and "active-controlled" using a standard of care, FDA said. "Placebo-controlled trials are not appropriate for this indication," FDA noted.
FDA also explains that some patients will not be allowed to participate in the trial, such as those patients who have received antibacterial drug therapy for 24 of the 72 hours preceding the start of the trial. This is meant to ensure that the observed effect in the new trial is due to the new drug, and not the lingering effects of another drug.
Sponsors will need to take a microbiologic sample from each patient to confirm that each patient is in fact affected by the bacteria the drug is intended to treat. This may also help companies to identify additional strains which might be positively affected by the drug, FDA's guidance adds.
Perhaps most importantly, FDA has maintained a clinical endpoint established in its draft guidance document. "The primary endpoint of clinical success is defined as resolution of the baseline signs and symptoms of cIAI based on objective assessments of events from randomization until approximately day 28 [of the trial]," FDA writes in the guidance.
Clinical "failure" would occur if the patient died, became infected, required unplanned surgery or required additional antibacterial drug therapy, FDA explained.
Complicated Intra-Abdominal Infections: Developing Drugs for Treatment (FR)
Tags: Guidance, Final Guidance, cIAIs, Complicated Intra-Abdominal Infections
Regulatory Focus newsletters
All the biggest regulatory news and happenings.