Category Archive
The following is a list of all entries from the marketing category.
Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence
Filed in clinical, marketing, pre-clinical, March 1, 2010, 11:47 amOrganisations that commented on the draft Guideline as released for consultation
Drug Regulators, MHRA, Publish Best Practice Guidance on the Same of Pain Relief
Filed in marketing, , 11:09 amMedicines for pain relief on general sale are effective and acceptably safe when used according to the label instructions. But there is evidence to show that people sometimes use large quantities of these medicines impulsively
Drug Regulators, MHRA, Publish Consultation Document on ARM 65 Algopain-EZE 140MG Medicated Plaster, Request to Reclassify a Prodcut from POM to P
Filed in marketing, February 27, 2010, 11:38 amConsultation ARM 65 seeks your views on the reclassification from POM to P Algopain-eze 140 mg Medicated Plaster. The Reclassification Summary and Patient Information Leaflet as provided by the applicant company are displayed below
Drug Regulators, FDA, Publish Guidance For Industry on Content of a Compleate Submission for the Evaluation of Proprietary Names
Filed in manufacturing, marketing, February 17, 2010, 12:06 pmThis guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates)
Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products
Filed in marketing, February 13, 2010, 11:45 amThe MHRA are writing to consult you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products – within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).
Drug Regulators, MHRA, Publish Consultation, Intention to Amend the Medicines for Human Use Regulations 2008 (SI2008/1692)
Filed in marketing, February 12, 2010, 11:41 amThis consultation notifies interested parties that further amendments will be made to the Medicines For Human Use (Prescribing By EEA Practitioners) Regulations 2008
(2008 Regulations). This consultation seeks views on how current guidance can be expanded to provide additional support for community pharmacists following forthcoming legislative changes.
Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs
Filed in clinical, licensing, marketing, February 7, 2010, 4:55 pmThis guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)).
Drug Regulators, FDA CDER, Publish Guidance to Pharmacies on Compounding Oral Suspension
Filed in manufacturing, marketing, January 24, 2010, 10:04 amThis guidance provides recommendations to pharmacies on the advance compounding of Tamilfu oral suspension to provide multiple prescriptions. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.
Drug Regulators, FDA, Publish Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.
Filed in devices, marketing, January 11, 2010, 9:07 amFDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining
Drug Regulator, MHRA, Starts Consultation on Measures to Strengthen the Medicines Supply Chain and Reduce the Risk of Counterfit Medicines
Filed in marketing, January 5, 2010, 8:26 amThis consultation meets the MHRAs commitment to undertake a further consultation on specific proposals designed to strengthen the medicines supply chain in the UK
