• RAPS' LatestRAPS' Latest

    How to be a Regulatory Leader

    Increasingly, regulatory professionals need to be effective leaders. Not only are they leading regulatory departments and cross-functional work groups, they also are being called upon to play key roles on corporate and organizational leadership teams. RAPS’ Scope of Practice Study shows that regulatory professionals now spend up to a third of their time working on strategy or business-related duties. Recognizing the value regulatory experts bring to the C-suite, s...
  • Feature ArticlesFeature Articles

    Writing Skills for the Regulatory Professional

    Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. Kumar has been a teacher, practitioner, innovator and researcher in the healthcare regulatory and scientific professions for 18 years. This article is an introductory overview of his upcoming book. Regulatory professionals have to write highly technical documents for a variety of audiences. These documents include clinical study reports, protoco...
  • RAPS' LatestRAPS' Latest

    J&J’s Regulatory Executives Groomed as Business Leaders

    Over the past decade, life sciences companies have increasingly realized that regulatory expertise is a mission-critical business asset. The amount of time regulatory professionals spend on business and management-related duties has risen sharply at all job levels, according to RAPS’ own Scope of Practice & Compensation Study . Some, more forward-thinking companies are taking this a step further, actively grooming regulatory professionals to be business leaders and crea...
  • FDA Issues Guidance on Qualifying for Device User Fee Exemptions, Reductions

    Last week, the US Food and Drug Administration (FDA) released all of the updated user fees various regulated industries will need to pay to the agency in the coming 2014 fiscal year, including special exemptions for some medical device companies. Now FDA is out with a new guidance document meant to explain exactly which medical device companies are eligible for reduced rates, and how to determine eligibility. Background Since the Medical Device User Fee Act (MDUFA) ...
  • US Agency Launches Investigation Into Veterinary Pharmaceutical Industry

    The US Federal Trade Commission (FTC) is announcing an investigation into competitive issues in the veterinary pharmaceuticals market after concerns were raised to it regarding the pricing of medications and possible anti-competitive issues. "American consumers spend a tremendous amount of money on medications for their pets every year," FTC Chairman Jon Leibowitz explained in a statement. "High prices on these medications mean that consumers have less money for necessit...
  • FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers

    The US Food and Drug Administration (FDA) has released new guidance on how small medical device companies can qualify as an FDA-approved small business and be eligible to pay reduced fees under the Medical Device User Fee Act (MDUFA) . FDA's Guidance for Industry and FDA Staff and Foreign Governments: FY 2012 Medical Device User Fee - Small Business Qualification and Certification  notes small businesses are authorized to pay "substantially reduced" fees under t...
  • Brazil: New IVD Guidance Aims to Assist Small Businesses

    A new guidance manual for the in vitro diagnostic (IVD) business sector is intended to assist companies in how to obtain the right to market their products in Brazil.  The Manual was developed by Brazil's national regulatory agency, Anvisa, in collaboration with the Brazilian Agency for Industrial Development (ABDI) and the Agency for Support to Entrepreneurship and Small Business (Sebrae).  The collaborative effort is especially intended to assist local com...
  • Paper: Small Companies Need Regulatory Assistance from EMA

    The European Medicines Agency (EMA) needs to assist companies-particularly small businesses, academic institutions and charities-in the development of advanced-therapy medicines, claims a new paper written by members of the Committee for Advanced Therapies (CAT) in the journal Molecular Therapies . These smaller drug development entities often lack the resources necessary to "navigate regulatory procedures," including clinical trials and application submissions. The pa...