News
FDA: Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing
29.05.2009
This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing
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FDA: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis Small Entity Compliance Guide
28.05.2009
On September 29, 2008, FDA published in the Federal Register a final rule (73 FR 56477, corrected at 73 FR 66754, November 12, 2008) that amended its regulations on the calcium and osteoporosis
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European Commision: Pharmaceutical legislation aligned with the new regulatory procedure with scrutiny
28.05.2009
Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to
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EMEA: Rules for the implementation of Regulation (EC) No 297/95 as amended on fees payable to the European Medicines Agency and other measures
27.05.2009
The rules apply to:
Scientific advice and protocol assistance
Scientific services
Extension of marketing authorisations
Type II variations
Annual fee
Administration
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EMEA: Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs)
27.05.2009
Annex 6.2 of Volume 9A of the Rules Governing Medicinal Products in the EU ...
FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion
27.05.2009
This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk
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EMEA: Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis
22.05.2009
This Guideline is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of ankylosing spondylitis (AS), a chronic inflammatory disease that affects
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EMEA: Guideline on the Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C
22.05.2009
The aim of this guideline is to provide guidance on the clinical development of compounds for the treatment of Chronic Hepatitis C (CHC). It should be read in conjunction with updated and
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EMEA: Clinical Investigation of Medicinal Products used in the Treatment of Osteoarthritis
22.05.2009
This document is intended to provide guidance on the clinical evaluation of medicinal products in the treatment of osteoarthritis (OA). OA is a flaring degenerative arthropathy and a disorder
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EMEA: Questions/answers on Endotoxin Testing and Sterility Testing at the end of shelf-life
22.05.2009
Is endotoxin testing considered essential at the end of shelf life to confirm parenterals to be pyrogen-free?
Is sterility testing considered essential at the end of shelf life to confirm
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