Drug Development Consultant and Regulatory Consultant

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FDA Publishes New Guidance Page – Memoranda to Blood Establishments

Blood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.

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Drug Regulators Publish Guidance for Allogenic Pancreatic Islet Cell Products

This guidance provides recommendations to manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus

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Drug Regulators Publish Draft Guidance on Development, Analysis and Presentaion of Microbological Data for Systemic Antibarterial Drugs

The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product.

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Drug Regulators Publish Guidance on End-of-Phase 2a Meetings

This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs).

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Drug Regulators Publish Draft Guidance on Biosimilars for Recombinant Erthropoietins

This guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed.

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Drug Regulators Publish Draft Clinical Guidelines for Cancer Vaccines

This guidance provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine, recommendations on critical clinical considerations for investigational studies of these products

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Twitter Weekly Updates for 2009-10-25

Presenting a business plan is more than the science! And more than market sizes! Its alllll about dynamics! Its just so important! #

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Drug Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Two guidelines have been developed by the Vaccine Working Party (VWP) on Pandemic
Influenza vaccines:

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Drug Regulators Publish Q&A on ICH M2 – Common Technical Document for the Registration of Pharmaceuticals for Human Use

This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD SpecificationThis question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification

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Drug Regulators Publish Draft Guidance on Development of Similar Recombinant Erythroproetins Containing Prodcuts

Drug Regulators EMEA publish Guidance on the Development of Similar Biological Products Containing Erythropoietins.
Full Guidance Here.
This guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy [...]