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Latest News | 22 May 2012

EMA Releases Guidance on Electronic Submission of Veterinary Applications

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The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format.The document, [Read More...]

Tags: Applications Dossier Electronic EMA Guidance Q&A Veterinary
Latest News | 26 April 2012

EMA Publishes Updated Guidance on Premarketing, Postmarketing Procedures

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The European Medicines Agency (EMA) has released updated guidance on procedural advice for its post-authorization and pre-authorization procedural advice, providing regulatory professionals with [Read More...]

Tags: Advice Answers EMA Postauthorisation Postauthorization Pre-authorisation Pre-authorization Q&A Questions
Latest News | 18 April 2012

EMA Posts Revised Integrated Guidance on Use of Centralized Procedure

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The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure.EMA’s 18 April revision of the Q&A document represents [Read More...]

Tags: Advice Centralised Procedure Centralized Procedure EMA Guidance MAH Post-Authorisation Post-Authorization Q&A
Regulatory Update | 12 April 2012

EMA Releases New Biosimilar Q&A Guidance

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The European Medicines Agency (EMA) has published a new guidance document that brings together in a single place a number of regulatory and procedural questions on biosimilars. It provides an overview [Read More...]

Tags: Biosimilars EMA Procedural Document Q&A
Latest News | 27 February 2012

FDA Releases New Draft Guidance on PET Drug Products

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The US Food and Drug Administration (FDA) released new draft guidance 27 February on Positron Emission Tomography (PET) drug products.FDA notes that Guidance: FDA Oversight of PET Drug Products [Read More...]

Tags: Answers Draft Guidance drug FDA Guidance PET Pharmaceuticals Positron Emission Tomography Q&A Questions
Latest News | 6 February 2012

FDA Releases New Draft Guidance on Positron Emission Tomography Products

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The US Food and Drug Administration (FDA) released new draft guidance for industry on 3 February that covers the regulation of positron emission tomography (PET) drugs. The guidance is intended to [Read More...]

Tags: ANDA Draft Guidance FDA NDA PET Positron Emission Tomography Q&A Questions and Answers
Latest News | 26 January 2012

New Q&A on Procedural Advice for Generic and Hybrid Product Applications Released by EMA

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The European Medicines Agency (EMA) released a new question and answer document on 25 January for applicants planning to use the Centralised Procedure to advance generic and hybrid product [Read More...]

Tags: Answer Applications Centralised Procedure EMA Generic Hybrid Q&A Question
Latest News | 12 January 2012

ICH Releases Additional Guidance on Combination Drug Toxicity Testing

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The International Conference on Harmonization (ICH) released a new Question and Answer document on 11 January that provides additional guidance on ICH document M3(R2) – Combination Drug Toxicity [Read More...]

Tags: EMA FDA Guidance ICH M3(R2) MHLW Q&A