FDA – Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness – June 19, 2018
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.
Tuesday, June 19, 2018
10:00am – 2:00pm (Eastern)
For more information go to https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm608748.htm
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
June 4, 2018
The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm
CECMED como observador ICH
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O CECMED participou pela segunda vez na qualidade de Observador na Assembléia do atual Conselho Internacional para a Harmonização de Requisitos Técnicos para Produtos Farmacêuticos deUso Humano (ICH), realizado desta vez em Montreal, Canadá, de 31 de maio a 1 junho. CECMED compartilhou informações com os membros, representantes da indústria, organizações internacionais, grupos de trabalho e com as outras oito Autoridades Reguladoras de Medicamentos que compõem a ICH, seguindo o programa estabelecido.
Mais informações pelo link http://www.cecmed.cu/content/cecmed-observador-ich
Anvisa recebe Auditoria da União Europeia para Insumos Farmacêuticos
Inspeções serão realizadas no período de 12 a 21 de junho com o objetivo de reavaliar a manutenção do status do Brasil com critério de White List.
Uma equipe de auditores da União Europeia (UE) esteve na Anvisa, em Brasília, nesta terça-feira 12 de junho, para dar início ao processo de avaliação da manutenção do status de país incluído na lista de países com equivalência nos controles de insumos farmacêuticos, denominada de White List.
Maiores informações pelo link http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4530380
Health Canada: BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric Patients
Audience
Healthcare professionals including hematologists, oncologists, hospital and oncology pharmacists, and cancer clinic staff
Key Messages
- Serious and fatal adverse reactions including “gasping syndrome” can occur in pediatric patients, particularly in neonates and infants treated with BLINCYTO containing benzyl alcohol as a preservative.
- BLINCYTO has recently been authorized with an additional option of preparing a 7-day infusion bag containing benzyl alcohol for patients weighing greater than or equal to 22 kg. It is not recommended for use in patients weighing less than 22 kg.
- When preparing bags of BLINCYTO solution for infusion in neonates, infants and patients weighing less than 22 kg, healthcare professionals are advised to only utilize preservative-free saline.
- The Canadian Product Monograph has been updated to reflect this new safety information
For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67016a-eng.php
Perú: Minsa publicó el proyecto de Reglamento que regula el uso medicinal del cannabis
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Para recibir aportes y comentarios a norma que busca garantizar el derecho a la salud y acceso a su uso terapéutico
16-05-2018
El Ministerio de Salud (Minsa) publicó el Proyecto de Reglamento de la Ley N° 30681, Ley que regula el uso medicinal y terapéutico del Cannabis y sus derivados, en su Portal Web Institucional.
El objetivo de la publicación es recibir las sugerencias, comentarios o recomendaciones de las entidades públicas o privadas y de la ciudadanía en general, por un plazo de noventa (90) días calendario las cuales podrán ser formuladas escribiendo al correo webmaster@minsa.gob.peconforme a lo dispuesto por la Resolución Ministerial N° 435-2018/MINSA suscrita por la ministra de Salud, Silvia Pessah.
Las personas e instituciones interesadas en conocer el contenido de la propuesta y realizar sus aportes podrán leer el proyecto de reglamento ingresando al enlace ftp://ftp2.minsa.gob.pe/normaslegales/2018/Resolucion_Ministerial_N_435-2018-MINSA.PDF que forma parte de los documentos en consulta publicados en el portal web del Minsa.
Más informaciones por el enlace http://www.digemid.minsa.gob.pe/main.asp?Seccion=3&IdItem=2134
FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.
For more information go to https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm610279.htm
