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

  • 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for oncology drugs intended to be used in combination regimens, the US Food and Drug Administration has released draft guidance for how oncology drugs used in combination regimens can be referenced by means of cross-labeling.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...
  • Regulatory NewsRegulatory News

    Promising mRNA tech comes with regulatory, CMC headaches

    As the buzz builds around messenger RNA (mRNA) technology’s use for two leading COVID-19 candidates, manufacturers and regulatory professionals are facing facts: This is not simple technology. Complex manufacturing processes, delivery vehicles that must be treated more as drug substances than excipients, and potential immunogenicity headaches are among the challenges industry faces as this promising technology is harnessed to address an increasing number of health condi...
  • Regulatory NewsRegulatory News

    Euro Convergence: Early consultation critical in overcoming gene therapy hurdles

    When it comes to advancing gene therapy products in the United States and Europe, the key is early consultation with regulators and identification of potential problems, experts said at the Euro Convergence 2020 virtual meeting. “It is better to do it earlier and establish a collaborative and educational approach to discussions,” advised Mridula Shukla, director of global regulatory affairs at Arcutis Biotherapeutics in Palo Alto, Calif.   Patrick Celis, PhD, head of ...
  • RoundupsRoundups

    FDA Approvals Roundup: New formulation for Ultomiris

    New formulation Ultomiris gets new formulation for blood-related disorders  Alexion’s Ultomiris (ravulizumab-cwvz injection) has been  approved  as a 100 mg/mL formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) for adults and children aged one month or older.  The  new  formulation of the complement inhibitor will cut annual infusion time by about 60%, or six hours, compared with the 10 m...
  • 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 gives draft adjuvant trial guidance for RCC, bladder cancer

    Two new draft guidances from the US Food and Drug Administration give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers. The first of the guidances released on 1 October addresses adjuvant treatment for bladder cancer, and the other addresses adjuvant treatment of renal cell carcinoma (RCC).   “Currently, there is significant variability in the design, conduct, and analysis of clinical trials” that examine adjuvant ...
  • Regulatory NewsRegulatory News

    Drugmakers get return-to-normal guidance from FDA

    A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic.   “This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduce...
  • Feature ArticlesFeature Articles

    An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case

    This article provides an overview for writing up the biological drug substance manufacturing process and process controls. The authors provide an example for the manufacturing of biological drugs consisting of a cytokine. They cover several complex manufacturing steps and details expected to be included in Section 3.2.S.2.2 (Description of Manufacturing Process and Process Controls) of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Us...
  • 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...
  • 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

    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 drafts recommendations for studying cancer drugs in patients with CNS metastases

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases.   FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.   "There are few effectiv...