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 05 February 2014 | By Alexander Gaffney, RAC,
US regulators performed fewer inspections in 2013 than at any time in the previous five years, according to a new analysis released this week.
The analysis, performed by FDAzilla, a business which tracks and sells FDA inspections and reports, found that the agency performed 37,774 inspections in 2013.
While numerically impressive, it was nevertheless a five-year low, the report noted.
"It's the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522)," wrote Tony Chen, co-founder of FDAzilla.
In fact, an analysis of all inspection data going back to 2004 shows that FDA performed fewer inspections in 2013 than in any other year except for 2008.
It's also a 7.8% decrease from the year prior, and significantly below its 2011 high of 46,241 inspections.
While it's difficult to discern a reason for the drop from the data alone, it could be attributed to cuts in FDA's budget due to the Budget Control Act. Under the Act, FDA lost access to approximately $318 million in funding. Without that funding, FDA may have needed to cut back on the frequency of its inspections.
Jan
3,755
3,532
3,657
3,623
3,569
3,403
3,419
3,561
3,910
3,760
Feb
3,644
3,630
3,717
3,424
3,549
3,675
3,726
3,711
4,011
3,754
Mar
4,518
3,956
4,352
3,944
3,714
4,200
4,852
5,066
4,658
4,123
Apr
3,789
3,208
3,420
3,255
3,388
3,733
4,098
3,674
3,771
3,888
May
3,595
3,263
3,788
3,813
3,487
3,504
3,874
4,030
4,054
3,845
Jun
3,506
3,691
3,635
3,688
4,040
4,358
4,400
3,839
3,536
Jul
3,285
2,889
2,820
3,109
3,612
3,715
3,206
3,441
3,273
3,312
Aug
3,709
3,611
3,642
3,381
3,700
4,406
3,770
3,563
Sep
3,727
3,444
3,442
3,294
3,362
3,954
3,368
3,713
3,187
3,003
Oct
3,636
2,398
2,714
2,736
2,463
2,656
2,843
2,871
2,673
2,081
Nov
3,455
3,197
3,244
3,059
2,637
3,079
3,712
2,996
2,614
Dec
3,031
2,835
2,582
2,798
3,078
3,656
2,999
2,286
43,825
39,850
41,163
39,855
39,522
42,569
44,374
46,241
43,141
39,765
*Includes all inspections, including Food and Tobacco.
Tags: Latest News, inspections
Regulatory Focus newsletters
All the biggest regulatory news and happenings.