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 

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

[Original text in Spanish]

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.

For more information go to http://www.cecmed.cu/content/cecmed-observador-ich

For more informantio go to http://www.ispch.cl/sites/default/files/comunicado/2018/06/Notificaci%C3%B3n%20de%20retiro%20de%20mercado.%20.pdf

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

[Original Text in Spanish]

05-16-2018

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.

People and institutions interested in knowing the content of the proposal and make their contributions can read the draft regulation by entering the link ftp://ftp2.minsa.gob.pe/normaslegales/2018/Resolucion_Ministerial_N_435-2018-MINSA.PDF that forms part of the documents in consultation published on the web portal of the Minsa.

The Ministry of Health will be hosting its 9th Annual National Health Research Conference in November.

Research being conducted in four (4) main areas: (i) Oral Health (ii) Intentional and Unintentional Injuries (iii) Non-communicable Diseases, featuring cancers and (iv) Family Planning, will be showcased.

For more information go to :

Ministry of Health 9th Annual National Health Research Conference Call for Abstracts