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.
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.
CECMED participated for the second time in its capacity as Observer in the Assembly of the current International Council for the Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH), held this time in Montreal, Canada, from May 31 to 1. June. There he shared with the membership, representatives of the industry, international organizations, working groups and with the other eight Medicines Regulatory Authorities that make up ICH, following the established program.
Inspections will be carried out from June 12 to 21 with the objective of reassessing the maintenance of Brazil’s status with the White List criterion.
A team of European Union (EU) auditors was at Anvisa in Brasilia on Tuesday, June 12 to begin the process of assessing the maintenance of country status included in the list of countries with equivalence in the controls of pharmaceutical supplies, called the White List.
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
To receive contributions and comments to the norm that seeks to guarantee the right to health and access to its therapeutic use.
The Ministry of Health (Minsa) published the Draft Regulation of Law N ° 30681, Law that regulates the medicinal and therapeutic use of Cannabis and its derivatives, in its Institutional Website.
The objective of the publication is to receive suggestions, comments or recommendations from public or private entities and citizens in general, for a period of ninety (90) calendar days which may be formulated by writing to the email webmaster@minsa.gob. conforming to the provisions of Ministerial Resolution No. 435-2018 / MINSA signed by the Minister of Health, Silvia Pessah.
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.
This year, the IX CPANDRH will be held in San Salvador, El Salvador from October 24 to 26, 2018, in the Hotel Sheraton Presidente at Avenida De La Revolución, San Salvador, El Salvador.
