• RAPS' LatestRAPS' Latest

    Chicago Workshop to Help Regulatory Pros Communicate More Effectively

    Most regulatory professionals do not have a background—or often any training at all—in communications. Yet they are called upon every day to be effective communicators. Whether it’s communicating with their peers on a regulatory team, colleagues in other areas within their organizations, upper management, regulators, researchers, contractors or others, regulatory pros need to be clear, establish credibility and influence people in different disciplines and at many d...
  • 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...
  • 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...
  • Regulatory NewsRegulatory News

    Medical Device Data Systems to be Exempt from Regulation, FDA Says

    In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...
  • 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) ...
  • Do They 'Like' Us? FDA Wants Tool to Better Assess its Impact on Social Media

    The US Food and Drug Administration (FDA) doesn't always seem like it's listening to its stakeholders. But if a recent sources-sought notice posted to the Federal Business Opportunities (FBO) website is any indication, it's listening a lot more closely than most people would realize. A hallmark of many businesses in the last few years has been the use of analytics tools to gauge the impact of various "campaigns," including on social media. For example, by using special p...
  • FDA Preparing to Devote more Resources to Social, Mobile Outreach

    The US Food and Drug Administration (FDA) is, first and foremost, a public health agency responsible for regulating the safety and efficacy of healthcare products. But central to that mission is how it communicates with the public about those products, something made even more complicated with the advent of new technologies. Background These difficulties are put on display in a new report just published by FDA, which notes that the last two decades have seen the develop...
  • Device Groups Say FDA Communication Guidance Gets Additional Information Letters Wrong

    Several entities within the medical device industry are calling attention to a provision within a recent draft guidance published by the US Food and Drug Administration (FDA) that they say offers little in the way of clarification and could potentially be a sticking point during complicated and contested review proceedings. Background In March 2013, FDA released a long-awaited guidance entitled Types of Communication During the Review of Medical Device Submissions . T...
  • 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...
  • Senator: FDA Stonewalling Investigation into Secret Monitoring

    Senator Charles Grassley (R-IA) is not pleased with the US Food and Drug Administration (FDA). Grassley, who serves on the Senate Judiciary Committee, has been investigating FDA  for months after allegations were raised about the agency's handling of a whistleblowers within its medical device reviewing group, and whether the agency intercepted communications between  the whistleblowers and Congress. But those months have borne little other than frustration for...
  • 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...