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  • RoundupsRoundups

    FDA Approvals Roundup: Xywav, Qutenza, Orphengesic

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Xywav gets the nod as a low-sodium option for narcolepsy   Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates oral solution) has been approved as a therapy for cataplexy or excessive daytime sleepiness in children aged 7 years or older and adults who have narcolepsy, a chronic and debilitating neurologic condition f...
  • Regulatory NewsRegulatory News

    Cannabis clinical research clarified in draft guidance

    A new draft guidance from the US Food and Drug Administration (FDA) provides detailed information on the conduct of clinical research using cannabis and cannabis-derived compounds, including how to calculate levels of delta-9 tetrahydrocannabinol (THC), cannabis’ main psychoactive ingredient.   The draft guidance recommendations, which pertain only to human drug development, “are intended to provide clarity” in the wake of the 2018 Farm Bill, which removed low-delta-...
  • Feature ArticlesFeature Articles

    Designing a biologics manufacturing facility: Early planning for success

    This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspect...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS publishes updated Intro to Due Diligence book for regulatory pros

    Due diligence is the process of evaluating potential business transactions or partnerships to identify and mitigate risk. Given the complex global regulatory environment for developing, testing, manufacturing, and bringing to market products like pharmaceuticals, biologics and medical devices, regulatory professionals are often called upon as critical members of due diligence teams. RAPS’ new, updated second edition of Introduction to the Due Diligence Process , was ...
  • ReconRecon

    Recon: US pays $1.95B for Pfizer, BioNTech COVID-19 vaccine; Biogen lifts forecast on Tecfidera sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Gets $1.95 Billion to Produce Coronavirus Vaccine by Year’s End ( NYTimes ) ( Press ) Exclusive: Novavax executives could get big payday even if vaccine fails ( Reuters ) Among biotech venture capital firms, Flagship Pioneering got the best single-fund returns ( STAT ) White House considers drug pricing executive order, prompting GOP pushback ( The Hill...
  • Regulatory NewsRegulatory News

    Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine

    The public should have confidence in any COVID-19 vaccine approved by the US Food and Drug Administration (FDA), according to the testimony presented by five top pharmaceutical executives at a hearing of the House Energy & Commerce Subcommittee on Oversight and Investigations on 21 July.   The executives – representing AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer – also stressed that the agency does not appear to be lowering its standards to rush a vacci...
  • Regulatory NewsRegulatory News

    FDA kicks off GDUFA III reauthorization process

    In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency’s third GDUFA program.    GDUFA II, authorized in 2017, expires at the end of September 2022. The GDUFA II agreement had two major objectives in speeding access to ...
  • ReconRecon

    Recon: Drugmakers boost lobbying amid pandemic rush; Biogen to study Spinraza in patients treated with Zolgensma

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma Firms Boost Lobbying in Race for Virus Treatment, Vaccine ( Bloomberg ) ( STAT ) US Accuses Two Hackers of Stealing Secrets From US Firms for China ( WSJ ) White House to resurrect rebate rule ( Politico ) Biogen to study Spinraza in combination with $2 million Novartis drug ( Reuters ) ( Press ) Gilead lines up a $1.55B biotech buyout deal as CEO Dan ...
  • RoundupsRoundups

    Asia-Pacific Regulatory Roundup: TGA finds ‘clear examples’ of harm linked to medical software

    Reviews conducted by Australia’s Therapeutic Goods Administration (TGA) found “clear examples” of harm caused by medical software.   TGA searched the medical literature for articles on the safety and efficacy of medical software as part of an assessment of how it regulates the sector. In parallel, the administration reviewed its data, revealing that software faults caused 20% of all medical device recalls over the past five years. While the recalls primarily related to...
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    RAPS AnnouncementsRAPS Announcements

    Elemed and RAPS announce a partnership for Elemed’s Mentoring Academy

    RAPS and Elemed, a leading European technical recruiter in the medical technology industry, have signed a partnership to offer Elemed’s Mentoring Academy to RAPS members at special rate. With the first program launching in September, Elemed’s Mentoring Academy is the first of its kind—a hybrid mentoring and training program—specifically designed for regulatory, quality and clinical professionals within the MedTech and in vitro diagnostics (IVD) industry. “The goal of th...
  • Regulatory NewsRegulatory News

    Six more months tacked onto regenerative medicine enforcement date

        The end of a discretionary enforcement period for regenerative medicine products was pushed back by another 6 months, according to a final guidance issued today by the US Food and Drug Administration (FDA).   Today’s updated guidance shifts the enforcement date but otherwise leaves unchanged a 2017 guidance addressing regulatory considerations for “minimal manipulation” and “homologous use” of human cells, tissues and cellular and tissue-based products (HCT/P...
  • Regulatory NewsRegulatory News

    FDA issues enforcement policy for coronavirus transport media

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.   The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW ...