With the European Medicines Agency’s (EMA) departure from London and loss of UK expertise (about 60 of the 897 EMA staffers are from the UK) looking more likely, the agency on Wednesday released a report outlining its successes from 2016, when 27 new medicines were authorized and several new programs took shape. Like in the US, EMA is increasingly approving new drugs more quickly for those with unmet needs. In 2016, more than one in three new medicines was recommen...

Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading! Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers : A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs. Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 :...

RAPS headquarters will close this year the week of 26 December and reopen 3 January 2017. Online orders from the RAPS Store may still be placed and will be shipped while the office is closed, and RAPS will still take 20% off all orders placed in December with the code: DEC20OFF. However, please note shipping times may be delayed for orders placed from 23 December through 4 January. Regulatory Focus will publish news and the RF Today e-newsletter will continue d...

This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...

This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions, including: Innovation and Technology: Practical Applications for Regulatory Zika Real World Evidence Faster Patient Access to Innovative and Critical Medicine Recent Developments in Off-Label Promotion Medical Devices Innovation and Technology: Practical Applications for Regulatory A panel discussion explored ...

India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders. In June, India announced it was abandoning its plan to amend the Drugs and Cosmetics Act of 1940 in favor of developing new, separate legislation for the regulation of drugs and medical devices. Shortly afterwards, CDSCO released preliminary draft rules est...

Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible. Trautman, who left her position as associate director for international affairs at FDA's Center for Devices and Radiological Health (CDRH) for a position at NSF International earlier this year, was instrumental in writing FDA's 1996 Quality...

RAPS will bring the largest annual gathering of the global healthcare regulatory profession to San Jose, CA, 17–20 September . The 2016 Regulatory Convergence will take place at the San Jose McEnery Convention Center. The Convergence is expected to draw more than 2,000 participants, including healthcare product regulators, scientists, researchers and regulatory professionals from life sciences companies. This year marks RAPS’ 40th anniversary, and the Converg...

RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession , which can be downloaded at www.RAPS.org/sop . Among the most significant findings, r...

When the 2016 Regulatory Convergence begins next month in San Jose, R “Ray” Wang , principal analyst, founder, and chairman of Silicon Valley-based Constellation Research, will kick things off Sunday evening, 18 September, with opening keynote remarks. Wang is a noted Silicon Valley strategic thinker with expertise in areas including technology and innovation, digital disruption, business model design, engagement strategies and customer experience. He also starte...

Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022. The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projec...