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  • Regulatory NewsRegulatory News

    FDA Alerts on Increased Risks Linked to Pfizer’s Xeljanz

    The US Food and Drug Administration (FDA) alerted the public late Monday of a post-marketing safety clinical trial for Xeljanz (tofacitinib) that found an increased risk of lung blood clots and death in patients with rheumatoid arthritis (RA) who were taking a dose of 10 mg twice daily. The drug safety communication noted the increased risk was observed in the post-marketing trial set as a requirement on Pfizer following the first approval  of Xeljanz in 2012. It comes...
  • Regulatory NewsRegulatory News

    FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies

    A paper appearing in the New England Journal of Medicine on Thursday argues that the US Food and Drug Administration (FDA) is not doing enough to ensure drugmakers complete postmarketing studies required by the agency at the time their drugs are approved. In 2007, FDA gained the authority to establish postmarketing requirements for new drugs and biologics under the Food and Drug Administration Amendments Act (FDAAA). The act also gave FDA the authority to warn or fin...
  • Regulatory NewsRegulatory News

    Fears Over Device Surveillance Amid Talk of Deregulation

    A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts. In a viewpoint published in JAMA on Thursday, Joshua Sharfstein of Johns Hopkins Bloomberg School of Public Health, and Rita Redberg and Alison Jacoby of the University of California, San Francisco Medical Center, point to the recent debate over power morcellators as ...
  • Regulatory NewsRegulatory News

    FDA Details Combination Product Postmarket Safety Reporting Requirements

    The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting. In a webcast last week, John Weiner, associate director for policy at the Office of Combination Products (OCP), explained which parts of the rule manufacturers should be following now, and which will they will be required to comply with beginning July 2017. Weiner ...
  • Regulatory NewsRegulatory News

    FDA Warns Specialty Pharma Company Over Adverse Event Reporting

    The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting. FDA sent the warning letter following an inspection on 21 July 2016, during which FDA says it found the company lacked written procedures for gathering, evaluating and reporting postmarketing adverse drug experiences (PADE), which are required under federal regulations. "Given your reli...
  • Regulatory NewsRegulatory News

    FDA Sees Better Industry Compliance With Postmarket Requirements

    A new report from the US Food and Drug Administration (FDA) reveals improvements made by industry in complying with postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for Fiscal Year (FY) 2015. In October, FDA released a lengthy and complicated report detailing industry compliance with PMR/PMC reporting requirements for FY2013 and FY2014. Background Under federal regulations, companies are required to submit an annual report to FDA for each post-a...
  • Regulatory NewsRegulatory News

    FDA Report Offers Complicated Picture of Industry Compliance With Postmarket Requirements

    The majority of ongoing postmarketing requirements (PMRs) and postmarketing commitments (PMCs) from Fiscal Years 2013 and 2014 were on schedule, but a large number of companies are still struggling to meet some of these regulatory requirements on time, the US Food and Drug Administration (FDA) said in a new report issued Friday. The slew of data released by FDA offer a murky look at how drugmakers meet such postmarket requirements once a new drug or biologic is ...
  • Regulatory NewsRegulatory News

    FTC Sues Drugmakers for Not Marketing Authorized Generics

    The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws. The complaint alleges that Endo Pharmaceuticals and several other drug companies violated antitrust laws by blocking access to generic versions of the pain drug Opana ER (oxymorphone) and the local anest...
  • Regulatory NewsRegulatory News

    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
  • Regulatory NewsRegulatory News

    Is a Drug Unsafe or Just Unprofitable? How a Lack of Data Clouds Regulatory Classifications

    Regulatory professionals are frequently concerned with getting pharmaceutical products approved for use and available to consumers. But as a new paper in the Journal of the American Medical Association (JAMA) explains, the way in which drug products are withdrawn from the market can have significant implications for both regulators and patients as well. Background Writing in JAMA Internal Medicine , Vinay Prasad, an official associated with Johns Hopkins University...
  • When are Postmarketing Trials Required for Medical Devices? New FDA Guidance Explains

    Earlier this week, the US Food and Drug Administration (FDA) launched the Expedited Access Premarket Approval program (EAP) , a new program aimed at getting innovative medical device products to needy patients more quickly by expediting the regulatory review of the products and their manufacturing processes. But in addition to the guidance document detailing the program, FDA also issued a draft guidance document on which clinical data FDA will expect companies to have a...
  • In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...