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

  • Regulatory NewsRegulatory News

    From FDA: How to conduct DDI studies with acid-reducing drugs

    A new draft guidance from the US Food and Drug Administration (FDA) addresses how to conduct drug-drug interaction studies with acid-reducing medicines that can make the gastric environment more alkaline.    Medicines such as proton pump inhibitors and histamine H2 receptor antagonists, dubbed acid-reducing agents or ARAs, are in wide use and many are available without a prescription. “ARAs can affect the solubility and dissolution characteristics of orally administere...
  • RoundupsRoundups
    Regulatory NewsRegulatory News

    FDA Approvals Roundup: Imcivree, Danyelza, Ga 68 PSMA-11

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Imcivree okayed as first therapy for managing obesity in some rare genetic conditions Rhythm Pharmaceutical’s Imcivree (setmelanotide) has been approved for chronic weight management in patients aged 6 years or older with obesity related to three rare genetic conditions.   Imcivree is the first treatment approved for pro-opiomelanocortin...
  • Feature ArticlesFeature Articles

    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
  • Regulatory NewsRegulatory News

    Moderna files COVID vaccine EUA; adcomm set for 17 December

    The pharmaceutical company Moderna has filed an emergency use authorization request with the US Food and Drug Administration (FDA) for the coronavirus vaccine the firm co-developed with the National Institutes of Health (NIH).  The company's vaccine against COVID-19 will be considered at a 17 December meeting of the FDA's Vaccines and Related Biological Products Advisory Committee. Announcing the meeting, FDA Commissioner Stephen Hahn, MD, said that the advisory committ...
  • Regulatory NewsRegulatory News

    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
  • Regulatory NewsRegulatory News

    FDA finalizes guidances on complex generics meetings, drug development tools

    The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance developed as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II).   The guidance walks developers of complex generics through the process for scheduling formal meetings with FDA through the abbreviated new drug application (ANDA) process in a s...
  • Regulatory NewsRegulatory News
    RoundupsRoundups

    FDA Approvals Roundup: Zokinvy, Oxlumo, Xofluza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Zokinvy okayed as first therapy for rare premature aging diseases Eiger BioPharmaceuticals’ Zokinvy (lonafarnib capsules) has been approved for reducing the risk of death from Hutchinson-Gilford progeria syndrome and treating certain processing-deficient progeroid laminopathies in patients aged 1 year or older. The rare genetic diseases cause pre...
  • Regulatory NewsRegulatory News

    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs)...
  • Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Abstract Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information,...
  • Regulatory NewsRegulatory News

    FDA launches online orphan submissions portal

    The US Food and Drug Administration (FDA) on Monday launched a new cloud-based submission portal for orphan drug designation requests, shifting away from the current paper and CD-based submission process. The new portal, first announced in January, is part of the agency’s orphan drug technology modernization effort and fits in with its broader technology modernization plans. The shift to electronic submissions follows a decade of increasing orphan drug designation reques...
  • Regulatory NewsRegulatory News

    Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December

    With favorable results from a completed Phase 3 clinical trial of their jointly developed vaccine against COVID-19, Pfizer and BioNTech have submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) according to Pfizer CEO Albert Bourla. The agency has set a 10 December date for the Vaccines and Related Biological Products Advisory Committee to review the EUA request. The meeting will be broadcast live on Facebook, Twitter, ...
  • Regulatory NewsRegulatory News

    Draft FDA guidance addresses oncology drug cross labeling

    In response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens, the US Food and Drug Administration has released draft guidance for how oncology drugs used in combination regimens can be referenced by means of cross-labeling.   "Oncology drug applications to the FDA often add investigational drugs to current regimens to create new combination regimens with greater efficacy or safety,” said Richard Pazdur, MD, di...