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DRUG REGULATORY AFFAIRS INTERNATIONAL DRUG REGULATORY AFFAIRS INTERNATIONAL BY DR ANTHONY CRASTO

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DRUG REGULATORY AFFAIRS · 8h ago

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues Today the U.S. Food and Drug Administration issued a warning letter to M...
DRUG REGULATORY AFFAIRS · 1W ago

Phytomenadione, Phytonadione, фитоменадион ,فيتوميناديون ,

Originally posted on New Drug Approvals: Phytomenadione, PHYTONADIONE, Phylloquinone Molecular Formula: C31H46O2 Molecular Weight: 450.707 g/mol [R-[R*,R*-(E)]]-2-Methyl-3-(3,7,11,15-tetrame...
DRUG REGULATORY AFFAIRS · 2M ago

ICH Q11 Q and A Document

ICH Q11   Q and A Document The topic of starting materials has been a vexed topic for some period. Indeed concerns relating to lack of clarity and issues pertaining to practical implementati...
DRUG REGULATORY AFFAIRS · 4M ago

Lanabecestat (formerly known as AZD3293 or LY3314814)

Originally posted on New Drug Approvals: Lanabecestat Molecular FormulaC26H28N4O Average mass412.527 Da Dispiro[cyclohexane-1,2′-[2H]indene-1′(3′H),2”-[2H]imidazol]-4”-amine, 4-methoxy-5”-me...
DRUG REGULATORY AFFAIRS · 4M ago

A review of fungal contamination in pharmaceutical products and phenotypic identification of contaminants by conventional methods

Article (PDF Available) in European Journal of Parenteral and Pharmaceutical Sciences 17(1):4-19 · January 2011 Abstract Microbial contamination of pharmaceutical products is one of the majo...
DRUG REGULATORY AFFAIRS · 6M ago

Report from the EMA-FDA QbD pilot program

Report from the EMA-FDA QbD pilot program In March 2011, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched, under US-EU Confidentiality...
DRUG REGULATORY AFFAIRS · 9M ago

EMA publishes Q&A on Health Based Exposure Limits – Does the 1/1000 dose criterion come again into play in Cleaning Validation?

In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in ...
DRUG REGULATORY AFFAIRS · 9M ago

Thailand Drug regulatory Update, Take a peep

http://www.fda.moph.go.th/eng/index.stm [PDF]Regulatory Requirement for the Approval of generic Drug in Thailand … http://www.jpsbr.org/index_htm_files/JPSBR14RV4029.pdf Apr 13, 2014 – Thail...
DRUG REGULATORY AFFAIRS · 9M ago

FDA publishes Final Guideline on GMP for Combination Products

In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and ...
DRUG REGULATORY AFFAIRS · 9M ago

GMP’s for Early Stage Development of new Drug substances and products

GMP’s for Early Stage Development of New Drug substances and products The question of how Good Manufacturing Practice (GMP) guidelines should be applied during early stages of development co...