• RAPSRAPS' Latest

    RAPS Virtual Career Fair to Take Place 10 December

    RAPS will host its final Virtual Career Fair of 2015 on 10 December from 12:00 to 4:30 pm EST. The online event provides a convenient venue for regulatory job seekers and recruiters to connect confidentially and in real time without having to leave the comfort of their homes or offices. Confirmed exhibitors for the 10 December fair are: BioNJ Globus Medical Abiomed Bovie Fresenius RTI Surgical Participation in the event is free for job seeke...
  • Regulatory NewsRegulatory News

    HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers

    The Department of Health and Human Services’ (HHS) invite-only Pharmaceutical Forum on Friday turned out to be more of a listening session for a range of stakeholders to explain concerns and discuss a number of potential ways to lower drug prices, some of which involve US Food and Drug Administration (FDA) reforms. HHS Secretary Sylvia Burwell kicked off the event by noting the steep cost increases for medicines, particularly for specialty drugs, which made up about $87 ...
  • Regulatory NewsRegulatory News

    South American Health Ministers Negotiate Lower Prices for Antivirals, Antiretrovirals

    As the drug pricing debate continues in the US, the ministers of health of 10 Latin American countries recently persuaded pharmaceutical companies to lower the prices of several HIV/AIDS and hepatitis C treatments. In the first of two planned rounds of negotiations, the health ministers of MERCOSUR (which includes Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela and associate countries Chile, Peru, Colombia and Ecuador) earlier this week agreed to purchase the HI...
  • Regulatory NewsRegulatory News

    What FDA Can and Can’t Do to Help Lower Rising Drug Prices

    Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. And sure enough, FDA doesn’t dip its toe into the pricing bog while deciding whether to approve or reject a new drug, and it also doesn’t negotiate with pharmaceutical companies over how to price drugs. But some FDA regulations do have a direct impact on drug prices, and with so...
  • Regulatory NewsRegulatory News

    AMA Calls to Ban DTC Advertising for Drugs, Medical Devices

    Physicians at the American Medical Association (AMA) on Tuesday called to ban direct-to-consumer (DTC) advertising for drugs and devices because of the negative impact of the commercially driven promotions. Physicians revealed concerns that the increase of ads in the US (only the US and New Zealand allow DTC advertising for drugs and devices) is driving demand for newer, more expensive treatments even though less-costly alternatives may be more effective. AMA Board Chai...
  • Regulatory NewsRegulatory News

    How the Clinton, Sanders Plans to Lower the Rise of Drug Prices Will Impact the FDA

    Democratic presidential candidates Hillary Clinton and Sen. Bernie Sanders are attempting to take on an issue the US Food and Drug Administration (FDA) can't control: rising drug prices. But some of their proposals would directly impact FDA authority. On Tuesday, Clinton unveiled a plan that would decrease the market exclusivity for biologics from 12 years to seven years, require drugmakers to spend a minimum amount of money on research and development (R&D), bar ph...
  • RAPSRAPS' Latest

    RAPS to Host Career Fair in Minneapolis

    On 24 September, RAPS will host a career fair for regulatory professionals and other interested job seekers in Minneapolis. The fair will take place 5:30–8:30 pm at the Marriott Minneapolis West and will give attendees a chance to network and meet in person with hiring managers and recruiters from a number of leading medical device and biotech organizations seeking to fill regulatory positions in the Twin Cities area. Participating exhibitors include: ACI...
  • RAPSRAPS' Latest

    RAPS to Host San Jose Career Fair

    On 10 September, RAPS will host a career fair and networking event for regulatory job seekers and employers in the San Jose area. The event will be held from 5:30 to 8:30 pm PDT at the Biltmore Hotel & Suites in Santa Clara, CA, and will give attendees a chance to network and meet in person to discuss open regulatory positions and career opportunities. The career fair is free for job seekers to attend. To register, fill out this online form . Employers int...
  • RAPSRAPS' Latest

    RAPS Virtual Career Fair to Take Place 13 August

    RAPS will host another in its series of Virtual Career Fairs this Thursday, 13 August from 12:00 to 4:30 pm EDT. The event, held completely online, provides a venue for regulatory job seekers and recruiters to connect conveniently, confidentially and in real time without having to leave their desks. Confirmed exhibitors for the 13 August fair are: Mylan Globus Medical Hollister Arazy Group Participation in the event is free for job seekers, who ...
  • Feature ArticlesFeature Articles

    The Untold Compliance Story Behind Sunshine Data

    Under Section 6002 of the Patient Protection and Affordable Care Act (commonly referred to as the Sunshine Act ), data must be reported to the Centers for Medicare and Medicaid Services (CMS) by pharmaceutical and medical device manufacturers regarding promotional, research, consulting and other support activities. 1 These data tell a very public story about those activities and the recipients of any fees or transfers of value behind them. Unfortunately, negative pu...
  • RAPSRAPS' Latest

    RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable

    No healthcare product, no matter how innovative or essential, will make it to patients without regulatory approval. Every regulatory professional knows this. But there is another critically important factor involved in getting treatments to patients that you may not know as much about—a concept known as market access. The elements of market access include reimbursement and the evidence necessary to secure it from payers, pricing and coverage policy. These areas ...
  • RAPSRAPS' Latest

    RAPS Virtual Career Fair Planned for 18 June

    RAPS’ next Virtual Career Fair is planned for Thursday, 18 June 2015, from 12 to 4:30 pm EDT. RAPS has been hosting these online events regularly since 2010, and they have proved extremely popular. Average attendance is 200–300. This is will be the second one this year; the first was held in April. The Virtual Career Fair allows regulatory job seekers the opportunity to chat live in an interactive virtual environment with hiring managers and recruiters from to...