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  • Regulatory NewsRegulatory News

    CDC advisory committee ponders COVID vaccine priorities

    Health care workers would be among the first to receive vaccines against COVID-19 in a timeline presented to the Centers for Disease Control and Prevention’s (CDC’s) vaccines advisory committee. The proposed scheme would have essential workers next in line for vaccination, ahead of those with serious medical comorbidities and most of the elderly. In a 23 November meeting, CDC’s Advisory Committee on Immunization Practices (ACIP) heard presentations and advice from a work...
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    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)...
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    WHO proposes update of GMPs for investigational products

    The World Health Organization is revising its guidance to industry on good manufacturing practices for investigational drug products, including new recommendations for quality risk management. The draft working document , which was released in November 2020, is open for public comment until 6 January 2021. The draft is expected to be revised and go through a second round of public comment before being presented to the WHO’s Expert Committee on Specifications for Pharmac...
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    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...
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    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, ...
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    FDA releases draft guidance for drug interaction studies with combined oral contraceptives

    The US Food and Drug Administration (FDA) has issued draft guidance for industry on performing clinical studies to look at the potential interactions between an investigational drug and combined oral contraceptives.   Interactions with other therapies can impact the efficacy and safety of combined oral contraceptives by affecting the enzymes involved in metabolizing progestins and estrogens. “For example, decreased progestin concentrations can lead to unintended pregna...
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    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...
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    FDA offers new Q&A on biosimilars and interchangeable products

    In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars.   When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.   In the first of four questions and answers in the draft guidance, FDA explains how i...
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    WHO backs off on remdesivir as FDA issues another EUA

    The World Health Organization is recommending against the use of the antiviral remdesivir (Veklury, Gilead) for the treatment of COVID-19.   “The antiviral drug remdesivir is not suggested for patients admitted to hospital with COVID-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation,” according to the World Health Organization’s (WHO’s) Guideline Development Group, in a statement re...
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    FDA, Industry set priorities for BsUFA III

    At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US Food and Drug Administration (FDA) and industry shared their wish lists for the third iteration of the agency’s biosimilars review program.   While FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeab...
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    Experts propose changes to FDA’s Accelerated Approval Program

    A new white paper from the Friends of Cancer Research offers a blueprint for reimagining the US Food and Drug Administration (FDA) Accelerated Approval Program for drugs and biologics that treat serious and life-threatening illnesses. The white paper , released during the group’s annual meeting, recommends explicitly adding a more comprehensive risk-benefit assessment to the surrogate endpoints currently used as the basis for approval, a framework that would move the U...