US-India BioPharma & Healthcare Summit 2014

LEARN | SHARE | NETWORK | BENEFIT US-India BioPharma & Healthcare Summit 2014 Cambridge, Massachusetts, USA As the pharmaceutical industry continues to globalize, Novatek understands the valuable need to foster as many international collaborations as possible. For the second year in a row, Novatek was pleased to be invited to the US-India BioPharma & Healthcare…

Novatek International organized an open forum with Hon. Congresswoman Leah Paquiz | Manila, Phillipines

            Novatek’s objectives during this event were: To provide an update on global trends and guidelines on health and healthcare issues (and present the Novatek Solutions Suite and examples of its capacity building activities in the region). To identify priority capacity building needs of the Philippine healthcare community  to meet…

MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs.  The Comment period will be 90 days. Please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT document.

610.12 CBER PROPOSED STERILITY TESTS

PART 610.12 — CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED   Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. For additional information, please see below for a summary or visit the enclosed web site for the full release http://www.gpo.gov/fdsys/pkg/FR-2011-06-21/pdf/2011-15346.pdf The authority citation for 21 CFR part 610 continues to read…