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  • Regulatory NewsRegulatory News

    FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling

    In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA) , the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana. FDA's recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August . Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where med...
  • Regulatory NewsRegulatory News

    Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

    President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...
  • Regulatory NewsRegulatory News

    Senators Urge Obama to Take Action on Drug Prices

    Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday. Examples of ways Obama could help to lower drug costs include requiring drugmakers to provide rebates on prescriptions for Medicare Part D low-income subsidy enrollees “in the same way that it does already for Medicaid recipients,” the senators said, noting that about $120 billion c...
  • Regulatory NewsRegulatory News

    FDA Sees Record-High PMA Approval Rate for 2015

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005, according to a 371-page quarterl...
  • Regulatory NewsRegulatory News

    US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

    The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...
  • Regulatory NewsRegulatory News

    FDA Hires New Directors, Deputy Directors for Four Foreign Offices

    A big shakeup is underway at the US Food and Drug Administration's (FDA) foreign offices as four new directors and one deputy director were named to the agency's posts in China, Europe, India and Latin America. The shift to new leadership comes as the following employees have moved on: Christopher Hickey, Ph.D., (former director, China Office), Carl Sciacchitano (former acting director, India Office), Michael Rogers (former director, Latin America Office), and Bruce Ross...
  • Regulatory NewsRegulatory News

    Are You a Good Witch, or a Bad Witch?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a ...
  • India Takes Inspiration From FDA, EMA in Bid to Improve CDSCO

    India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), might receive a major overhaul and a new name if a proposal by the Ministry of Health is enacted, Bloomberg TV India reports. Challenges at CDSCO While India has developed into a pharmaceuticals powerhouse, its regulator has struggled to keep up with the growth of its pharmaceutical industry. In 2012, a report commissioned by an Indian parliamentary committee found CDSCO struggled with...
  • RAPS' LatestRAPS' Latest

    Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence

    Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff , MD, will speak to attendees of the 2015 RAPS Regulatory Convergence . RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore. Ostroff will speak 27 October, delivering a special keynote address, then he will participate in a panel discussion on key agency activities and initiatives. Other expert panelists are expected to be announced in...
  • Feature ArticlesFeature Articles

    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
  • Regulatory NewsRegulatory News

    Major Changes Set for Taiwan’s Medical Device Registration Process

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei. The regulatory changes will take effect starting 1 July 2015.  First, TFDA will introduce a two-step review program for marketing authorization appli...
  • RAPS' LatestRAPS' Latest

    FDA Expresses Desire to Work With Industry on CGMPs for Combo Products

    During RAPS’ and the Combination Products Coalition’s (CPC) recent workshop on current Good Manufacturing Practice (CGMP) for combination products, which took place on 1 April, the US Food and Drug Administration’s (FDA) lead presenter, John Barlow “Barr” Weiner, paused briefly to acknowledge the date’s popular connotation. “I just realized I should’ve inserted some sort of April fools [joke] in this presentation,” said Weiner, who is the associate director for polic...