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bioequivalence biological biotech biotechnology CBER CDER CHMP clinical clinical development Clinical Trials Consultancy CTD development Drug drug development eCTD EMEA EU FDA fund Funding GMP guidance Guidlines Herbal ICH ICH M3 ICH Q4B immunogenicity IRB labeling manufacturing Medical Devices MHRA monoclonal antibodies Non-clinical Nonclinical PDG pharmaceutical development pre-clinical preclinical Q4B Quality regualtory Regulations regulatory safety similar biological medicinal products twitter vigilance
Last 20 Entries
- Drug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases
- Drug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence
- Twitter Weekly Updates for 2010-03-07
- Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices – Cardiac Ablation Catheters
- Drug Regulators, FDA, Publish Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologicals.
- Drug Regulators, FDA, Publish Guidance on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
- Drug Regulators, FDA, Publish Draft Guidance for Industry, Non-Inferiority Clinical Trials
- Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence
- Drug Regulators, MHRA, Publish Best Practice Guidance on the Same of Pain Relief
- Twitter Weekly Updates for 2010-02-28
- Drug Regulators, MHRA, Publish Consultation Document on ARM 65 Algopain-EZE 140MG Medicated Plaster, Request to Reclassify a Prodcut from POM to P
- Drug Regulators, EMA (EMEA), Publish draft guidance on Clinical Investigations in the Treatment of Diabetes Mellitus
- Drug Regulators, EMEA (EMA), Publish a Concept Paper on the Need For Guidance on Clinical Investigations of Medicinal Products in the Treatment of Diabetes Mellitus
- Twitter Weekly Updates for 2010-02-21
- Drug Regulators, FDA, Publish Guidance For Industry on Content of a Compleate Submission for the Evaluation of Proprietary Names
- Drug Regulators, EMEA, Publish Addendum to the Note for Guidance on Evaluation of Medicinal Products Indicated for the Treatment of Bacterial Infections
- Drug Regulators, EMEA, Publish an Overview of Comments Received on Draft Guidance on Clinical Investigations of Medicinal Products Used in Osteoarthritis
- Twitter Weekly Updates for 2010-02-14
- Drug Regulators, EMEA, Publish Concept Paper on Need to Revise Points to Consider on the Clinical Investigation of Medicinal Products Other than NSAIDs in Rheumatoid Arthritis
- Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products
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