Latest News
|
14 January 2013
2 Likes 
2012 was a momentous year for both the regulatory profession and Regulatory Focus. In our first year as an online-only publication, we covered a quickly changing landscape, dealing with topics that
Read More...
Latest News
|
2 January 2013
0 Likes
The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high.US regulators approved
Read More...
Latest News
|
6 December 2012
0 Likes
The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims—the best two-year approval record in 15 years.The
Read More...
Latest News
|
27 July 2012
0 Likes
The US Food and Drug Administration (FDA) is potentially on pace to approve fewer new drug entities than it did in 2011, according to several sources.An analysis by The Street of the remaining 2012
Read More...
Regulatory Update
|
10 May 2012
0 Likes
Brazil’s reorganized national regulatory agency, Anvisa, said in remarks it is focused on establishing “a regulatory environment conducive to innovation."The remarks, by Anvisa’s CEO Dirceu Barbano,
Read More...
Regulatory Update
|
23 April 2012
0 Likes
ANVISA’s Advisory Council—a group including representatives of the National Confederations of Industry (CNI), Commerce (CNC) and Health (CNS) and councils that represent the health secretaries of
Read More...
Regulatory Update
|
16 April 2012
0 Likes
The 2012 Regulatory Agenda of the National Agency of Sanitary Surveillance (ANVISA) was published on 12 April in the Official Gazette (DOU) and includes the expansion of the national product
Read More...
Latest News
|
30 March 2012
0 Likes
The US Food and Drug Administration’s (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education,
Read More...
Latest News
|
6 March 2012
0 Likes
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released 5 March a list of all new and revised guidance documents that the agency plans to release during
Read More...
Focus Forward
|
8 February 2012
0 Likes
For more than 20 years, RAPS has studied the scope of practice and compensation of regulatory professionals. Through our biennial survey, we have tracked the growing and increasingly varied responsibilities of regulatory professionals and the accompanying need for new knowledge and competencies; the career development patterns of regulatory professionals; the compensation trends; and the role of professionals within their organizations.
RAPS has recently launched the 2012 Global Scope of Practice and Compensation Survey and this research may be even more important now than ever before. The health sector is undergoing change and scrutiny at an unprecedented pace while the need and demand for safe and effective healthcare products continues to escalate. The regulatory profession is growing worldwide and its role in helping to guide and shape the health sector may also be increasing. Now is the time to examine the profession and the roles its practitioners are playing at all levels.
Read More...