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  • Regulatory NewsRegulatory News

    Study: Few new drugs have high therapeutic value

    A new study published in The BMJ  finds that only a third of new drugs approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the decade from 2007-2017 have high therapeutic value, according to appraisal by one of five independent organizations.   However, the analysis found that drugs approved through expedited programs – and especially EMA’s programs – were more likely to have high therapeutic value.   “Most of the incre...
  • Regulatory NewsRegulatory News

    Stem cell clinic slapped with CBER warning

    A chiropractor who operates a stem cell clinic has received an untitled letter from the US Food and Drug Administration (FDA) for marketing intrathecal and intravenous injection of human stem cell and tissue-based products to treat such serious conditions as Parkinson’s disease and diabetes.   Michael Johnson runs Optimal Health Stem Cell and Wellness Institute, also doing business as OHSTEMCELL, in Appleton, WI. On 1 October, FDA’s Center for Biologics Evaluation and ...
  • Regulatory NewsRegulatory News

    FDA orphan drug updates at NORD Summit

    Officials from the US Food and Drug Administration (FDA) provided updates on the agency’s efforts to support the development of medical products for rare diseases at the National Organization for Rare Disorders (NORD) Summit this week.   In his keynote address on Thursday, FDA Commissioner Stephen Hahn said that FDA had already approved 51 orphan indications through July of this year and acknowledged that the agency’s Office of Orphan Products Development (OOPD) has se...
  • Regulatory NewsRegulatory News

    GAO details ongoing problems with FDA's lab safety oversight

    The US Government Accounting Office (GAO) found that many elements of an effort to improve laboratory safety at the Food and Drug Administration (FDA) have not been met, over three years after establishing an Office of Laboratory Safety. For example, the safety oversight office still cannot perform unannounced laboratory inspections, according to the report .   Prompted by the 2014 discovery of boxes of smallpox virus that were improperly stored in a laboratory cold r...
  • Feature ArticlesFeature Articles

    Getting to the point: Achieving clear communication with health authorities

    This article discusses the critical need for clear, precise, and consistent communication on the part of regulatory professionals in interactions and submissions with health authorities. It presents various approaches and offers examples for the regulatory professional to draw on to improve the clarity of such communications.   Introduction As a regulatory professional, one is constantly reaching for and achieving new goals. Whether it is initiation of a first-in-hum...
  • Regulatory NewsRegulatory News

    Good real-world outcomes for generic levothyroxine, despite narrow therapeutic index

    Generic versions of levothyroxine – a treatment for hypothyroidism -- are just as effective in restoring thyroid stimulating hormone levels as brand-name drugs in a real-world population, according to a recent study conducted by researchers from the US Food and Drug Administration, Yale University, and the Mayo Clinic.   Generic levothyroxine is prescribed about six-to-one over branded levothyroxine, but that still leaves generic prescriptions lagging behind prescrib...
  • Regulatory NewsRegulatory News

    Marks sheds more light on COVID-19 vaccine EUA guidance

    Two days after the US Food and Drug Administration’s (FDA) surprise publication of guidance setting criteria for emergency use authorization (EUA) for COVID-19 vaccines, Peter Marks, director of the Center for Biologics Evaluation and Research shared some of the thought process that went in to its recommendations.   One of the most significant recommendations in the guidance is FDA’s insistence on a median of two months of follow-up of Phase 3 trial participants follow...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs

    The US Food and Drug Administration (FDA) has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review emergency use authorization (EUA) requests for laboratory developed tests (LDTs).   That decision follows an announcement from the US Department of Health and Human Services that LDTs would not be required to undergo premarket review.   FDA will continue to pr...
  • Regulatory NewsRegulatory News

    Volunteers sought for CDRH cloud submission pilot

    Medical device firms can now apply to participate in a pilot US Food and Drug Administration (FDA) program for electronic delivery of medical device premarket submissions.   The pilot program, said FDA, provides a “voluntary alternate method” for developers to file premarket submissions to the Center for Devices and Radiological Health (CDRH) during the COVID-19 public health emergency. The pilot is intended to test the use of the Box cloud file sharing service, and to...
  • Regulatory NewsRegulatory News

    FDA warns Battelle over EUA conditions for N95 decontamination system

    The US Food and Drug Administration (FDA) on Wednesday warned Battelle Memorial Institute for failing to comply with some of the conditions of its emergency use authorization (EUA) for its decontamination system for N95 respirators.   The warning letter is the first FDA has issued concerning a product being used under an EUA during the COVID-19 pandemic.   In March, Battelle became the first organization to receive an EUA for a decontamination system for N95 respir...
  • RoundupsRoundups

    FDA Approvals Roundup: Alkindi, Haegarda, Kalydeco

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Alkindi approved as replacement therapy in children with adrenocortical insufficiency Eton Pharmaceuticals’ Alkindi Sprinkle (hydrocortisone oral granules) has been approved as a replacement therapy for adrenocortical insufficiency (AI) in children younger than 17 years. It is the first FDA-approved granular, lower-dose hydrocortisone formulati...
  • Feature ArticlesFeature Articles

    A regulatory anomaly: The NDA for water

    This is the story of a Code of Federal Regulations monograph for eyewash and a second regulation, which required a new drug application (NDA) for any drug sterilized by gamma irradiation. Both of these regulations did not take into consideration that water is a drug. Therefore, eyewash sterilized by gamma irradiation required an NDA. It took almost 14 years to eliminate the requirement of an NDA for eyewash sterilized by gamma. During this period, the company filed and rec...