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.
Posted 11 April 2013 | By Alexander Gaffney, RAC,
The story has it all: Mystery, intrigue, failures and secrecy. But it's not the latest plot line for a mystery novel-it's the latest out of the US Food and Drug Administration's (FDA) federal register docket, where a prominent life sciences law firm has petitioned the agency to hold off on posting a warning letter to an unidentified pharmaceutical company it represents.
The petition for a stay of action-in plain parlance, a request to delay an action-was made by the law firm Hyman, Phelps & McNamara, widely known in the industry for its FDA Law Blog and representation of life sciences firms.
The petition, made to Commissioner Margaret Hamburg, asks her to "stay certain decisions identified in a 15 March 2013 letter from the Acting Director of the Center for Drug Evaluation and Research's (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance."
That letter, wrote attorney Douglas Farquhar, had denied the company's request to reconsider certain issues pertaining to a 21 February 2013 Warning Letter sent to the company. While the company had appealed that warning letter on 15 March 2013, it has not yet exhausted its appeals process, the law firm argues.
In addition, the letter also says that the company believes its intellectual property may be in danger if the letter is posted. The company's appeal argues that further redactions of information from the warning letter were needed to "protect its confidential information and/or trade secrets pursuant" to federal law.
The rest of the letter is just as intriguing. Farquhar goes on to explain that at least part of the contested warning letter pertains to a pharmaceutical product "that has never been commercialized in the US," and thus shouldn't be noted in the warning letter.
"As the drug has never been commercialized in the US, the Company believes observations regarding the Drug were inappropriately included in the Warning Letter," Farquhar writes.
Without the benefit of further appeals, the un-named company would be subject to "irreparable injury" by giving its competitors insight into its confidential manufacturing process, and would thus have grounds to sue the agency.
"Should FDA refuse to stay the Warning Letter's publication before the appeals process is exhausted, the decision to publish the letter constitutes a final agency action warranting judicial intervention [under Darby v. Cisneros]," Farquhar wrote.
No timeline for action is listed in the letter.
Tags: Petition, warning letter, Latest News, pharmaceutical, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.