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.
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.
This guidance describes FDA’s enforcement approach with respect to over-the-counter (OTC) sunscreen products marketed without approved applications during the period before a final sunscreen monograph becomes effective. It is intended for manufacturers who market OTC sunscreen drug products without an approved application. OTC sunscreens are not yet the subject of an effective final monograph, and we continue to evaluate information relevant to defining conditions under which such products are generally recognized as safe and effective (GRASE) and not misbranded. However, OTC sunscreens marketed without approved applications and containing specified active ingredients (see section II., Background) are subject to labeling and testing requirements located at 21 CFR 201.327. Several other ongoing and planned rulemaking proceedings will also address these products.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Technicians of the Zonal Coordination 3 of the National Agency of Regulation, Control and Sanitary Vigilance (Arcsa) visited laboratories of natural products of Ambato, with the aim of verifying the hygienic-sanitary conditions, storage and production processes used for the elaboration of this type of products that are distributed nationwide.
“This type of inspection is carried out permanently throughout the area in order to provide recommendations for improvement in the development of natural products and food supplements, to protect the health of the population that consumes them,” said Carlos Barreno, technician of the Coordination Zonal 3 of Arcsa.
As part of the control, it was verified that the products comply with the approved labeling in the Sanitary Registry, as well as with the current sanitary regulations, to avoid possible cases of misleading advertising and confusion in the nutritional and therapeutic properties of said products.
The Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz, inaugurated today the “Second Symposium of medicinal cannabis for health professionals”, organized by the Director of CannabiSalud, Lorena Beltrán.
Be there for someone else. Give blood. Share life. 14 June 2018 Every year, on 14 June, countries around the world celebrate World Blood Donor Day. The event serves to thank voluntary, unpaid blood donors for their life-saving gifts of blood and to raise awareness of the need for regular blood donations to ensure the quality, safety and availability of blood and blood products for patients in need.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the National Federation of the Herbalist Industry, Traditional and Naturist Alternative Medicine A.C. (FNIHMATN), today signed a collaboration agreement whose main objective is to establish the necessary actions to have sanitary regulations that regulate the products and plants used by this sector as well as to improve and update the technical processes and continuous training.
Considering new sentinel events linked to the use of different drugs packaged in vials of similar appearance, the Ministry of Public Health warns health institutions to take precautions in the purchase of high-risk medications.
