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  • Regulatory NewsRegulatory News

    FDA warns firm: Test batches before, not after release

    An Indonesian firm was warned by the US Food and Drug Administration (FDA) for failures in product testing and method validation, among other breaches of current good manufacturing practice (CGMP).   In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released. “This discrepancy on batch release documents demonstrates a concern regardin...
  • ReconRecon

    Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Genentech scores sixth FDA approval in lung cancer with Gavreto ( Pharmafile ) US FDA Personnel Costs Drop: Is the Next Generation Taking Over? ( Pink Sheet ) Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA ( Pink Sheet ) Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma ( Forbes ) Here’s how Trump could bigfoot the FDA an...
  • Regulatory NewsRegulatory News

    COVID convalescent plasma guidance gets EUA updates

    Guidance for industry on the use of convalescent plasma for patients with COVID-19 has been updated to reflect the 23 August Emergency Use Authorization (EUA) for the investigational product. The guidance clarifies which pathways are available for use of COVID-19 convalescent plasma and announces a period of enforcement discretion for transition to collection requirements outlined in the EUA.   Updates to the US Food and Drug Administration (FDA) guidance account for...
  • RoundupsRoundups

    FDA Roundup: Sogroya, Onureg, Winlevi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Sogroya okayed as weekly therapy for adult growth hormone deficiency Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.   Until now, the only treatment option for patients with the disorder has been a daily formulation of t...
  • Regulatory NewsRegulatory News

    FDA updates deferral guidance for blood and plasma donation

    An update to guidance for industry on reducing the risk of transmission of Creutzfeldt-Jacob disease (CJD) through blood and blood components clarifies terminology and recommendations for patients who have received cadaveric pituitary human growth hormone. Some previous travel-based deferrals have also been revised or eliminated.   The revised guidance from the US Food and Drug Administration (FDA) addresses screening for variant CJD (vCJD) as well as other transmissib...
  • Regulatory NewsRegulatory News

    FDA releases draft guidance on PROs for device manufacturers

    Device manufacturers have new draft guidance from the US Food and Drug Administration (FDA) for the selection of patient-reported outcome instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing instruments, and the possibility of nesting patient-reported outcome instruments within real-world data sources.   The new draft was jointly issued by the Center for Devices and Radiological Health and the ...
  • Regulatory NewsRegulatory News

    FDA explains transfer of ownership policy for generics

    The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.   The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.   To transf...
  • Regulatory NewsRegulatory News

    October, no surprise: COVID-19 vax AdComm booked for the 22nd

    The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.   The announcement via the Federal Register and the FDA’s Twitter account comes a day after the head of the key US vaccine research accelerator Operation Warp Speed (OWS) signaled that a COVID-19 vaccine m...
  • Regulatory NewsRegulatory News

    FDA addresses nitrosamines in TB drugs

    Nitrosamine impurities have now been found in two tuberculosis drugs, prompting the US Food and Drug Administration (FDA) to clarify how it will handle elevated levels of the potential carcinogen in life-saving antibiotics.   Both rifampin and rifapentine are antibiotics used to treat tuberculosis, and rifampin is also used to treat other serious bacterial infections. Elevated levels of nitrosamines have been found in samples of both substances: the nitrosamine 1-methy...
  • RoundupsRoundups

    FDA Roundup: Kyprolis, Kesimpta, Cystadrops

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Kyprolis in triple combo approved for previously treated multiple myeloma Amgen’s Kyprolis (carfilzomib) has received an expanded indication as a once- or twice-weekly combination with Janssen’s Darzalex (daratumumab) and dexamethasone for relapsed or refractory multiple myeloma in patients previously treated with immunomodulatory drug based (...
  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • Regulatory NewsRegulatory News

    Cord blood firm warned by FDA on Zika screening

    A warning letter from the US Food and Drug Administration (FDA) warned a Puerto Rico-based firm for multiple violations related to human umbilical cord blood collection.   Banco Vida Corporation, located in San Juan, was inspected in September 2019 by investigators from FDA’s Center for Biological Evaluation and Research (CBER).  The increased risk for Zika virus for residents of Puerto Rico makes blood products from those individuals ineligible for use in human cell, ...