RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Democrats Revive Canada Drug Import Bill as Safety Questions Linger

    Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices. Sanders called the bill "critical" on Tuesday at a press conference, saying...
  • Regulatory NewsRegulatory News

    Transparency Push: EMA to Revise Policy on Document Access

    The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals. Since October 2016, EMA has published pharmaceutical trial data via its new website , including for: Mylan's aripiprazole, published most recently on 31 January 2017, Pfizer subsidiary Hospira's palonosetron, Praxbind  (idarucizumab), Tarcev...
  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

    In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so t...
  • Regulatory NewsRegulatory News

    PhRMA, Lilly and AbbVie Weigh FDA Plan to Study Twitter Drug Ads

    When the space of characters is limited, can a link to risk information be enough for drugmakers advertising their products on social media like Twitter? That’s the question the US Food and Drug Administration (FDA) asked last November and now industry is offering their opinions on the planned studies. As part of its planned study, FDA said on 7 November that it plans to conduct four studies, two involving Twitter and two using Google sponsored links, to determine how ...
  • Regulatory NewsRegulatory News

    21st Century Cures: Shifting the Balance of Negotiating Power

    The new 21st Century Cures law has proven to be divisive, with both advocates and critics getting hyperbolic on the law’s potential impact on the drug and medical device industries, as well as on the US Food and Drug Administration (FDA). Critics have said, among other things, that the law will forever tarnish FDA’s ability to keep dangerous new drugs and devices from hitting the market, while advocates believe it will open the US to new cures, particularly for rare dise...
  • Regulatory NewsRegulatory News

    ICH Working Group to Provide More Detailed Guidance

    The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues. According to a new concept paper endorsed by the ICH MedDRA (Medical Dictionary for Regulatory Activities) Management Board in November 2016, topics that ...
  • Regulatory NewsRegulatory News

    22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report

    With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA) on Thursday released a new report documenting 22 different times drugs, vaccines and medical devices since 1999 saw promising Phase 2 clinical trial results that were not confirmed in Phase 3 trials. FDA says the report “is not intended to assess why each of these unexpect...
  • Regulatory NewsRegulatory News

    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
  • Regulatory NewsRegulatory News

    New FDA Drug Approvals: Breaking Down the Numbers

    If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. And with only 18 FDA decisions on new drugs expected in 2017, according to BioPharma Catalyst , the number of FDA approvals may continue to decline to a level the industry has not seen since 2007, when 18 new molecular entities (NMEs) and new biologic license applications (BLAs) were approved. But as John ...
  • Regulatory NewsRegulatory News

    Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance

    Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information to the US Food and Drug Administration (FDA) are coming to an end, possibly as soon as 2019. On 28 December, FDA released draft guidance on the submission of manufacturing establishment information (MEI) in an electronic format. Twenty-four months after the agency finalizes this guidance, all MEI contained in new drug applications, abbreviated new drug applicat...
  • Regulatory NewsRegulatory News

    2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning

    Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June). On the positive side: Agreements on the reauthorizations for each of the user fee bills that will help fund FDA for the next...
  • Regulatory NewsRegulatory News

    FDA Warns Two Pharma Companies Over Misleading Ads

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements. One of the warnings was sent to Salt Lake City-based Spiraso due to “false or misleading claims and/or representations about the risks associated with Tuxarin ER” on the company’s website. Tuxarin is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults ...