News
EMA: Draft guideline on the clinical development of medicinal products for the treatment of HIV infection
03.10.2013
This guideline replaces EMEA/CPMP/EWP/633/02 Rev 2. It provides guidance on the clinical development of direct-acting antiretrovirals for the treatment of HIV infection. ...
EMA: Draft guideline on clinical investigation of medicinal products in the treatment of hypertension
03.10.2013
This is the fouth revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension. The main aim of this revision is to include more comprehensive
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FDA: Guidance for Industry: ANDA Submissions - Refuse-to-Receive Standards
03.10.2013
This guidance is intended to assist sponsors preparing to submit to the Food and Drug Administration (FDA) abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs
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EMA: Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract
03.10.2013
The note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [in the following called ‘guideline’] provides
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FDA: Draft Guidance with Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
26.09.2013
Due to the increasing interest and activity in the development of CGT products and because of their potential to address unmet medical needs the FDA published this draft guidance. It is intended
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EMA: EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals
26.09.2013
In May 2013 the CHMP adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. The date for coming into effect is the 1 December 2013. It will
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GMP: Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files
26.09.2013
According to the new Generic Drug User Fee Act (GDUFA) for the marketing authorisation of generic drugs in the USA, the Drug Master File (Type II) for APIs must undergo a completeness assessment.
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FDA: Guidance for Industry Endocrine Disruption Potential of Drugs: Nonclinical Evaluation
26.09.2013
This draft guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug
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EMA: Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product
20.09.2013
This reflection paper discusses the data requirements for nano-sized colloidal intravenous iron-based preparations developed as a treatment for iron deficiency with reference to a nano-sized
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FDA: Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND
20.09.2013
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects
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