Bluetooth GlucoMeter with iPhone

MedApps - Tools for Better Patient Satisfaction

Last month I have been speaking at international conference about Digital Marketing and Customer Experience Management. We have tried to bridge the gap between sales and regulatory requirements.

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes,1 cardiovascular disease,2 and infectious disease.3 Within the last two decades, the U.S. Food and Drug Administration (FDA) approved 19 new drug applications (NDAs) for fixed-dose combination drugs containing at least one new drug substance.4 More than half of these NDAs were approved in the last seven years.5 As with the development of any pharmaceutical product, developers of fixed-dose combination drugs will seek to maximize the patent protection and market exclusivities provided by the United States Patent and Trademark Office (USPTO) and the FDA, respectively.

India’s Marketing Regulations of Drugs

Approval of the drug product for import, manufacturing and marketing in India, its demonstration for safety and efficacy in humans is essential. The Rules 122A, 122B and 122D, 122 DA, 122DAA, 122E and Appendix I, IA and VI of Schedule Y of the Drugs & Cosmetics Act, 1945, describes the information/data required for approval of clinical trial and/or to import, manufacture, or market any new drug in the country. However, the requirements for approval of clinical trials and new drugs may vary depending on the nature of new drugs.

The whole 12 pages article is available for download at Repository section of FarmavitaR+.

Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure.

Until further notice, the applications considered will be those for solid oral dosage forms and oral solutions in accordance with article 10 of Directive 2001/83/EC, as amended.

Banishment of Unlicensed Herbal Remedies in the UK

Thousands of patients in the UK facing the decision about the banning of more than 200 herbal products. For some, this decision is discriminatory and shameful. The same measures are planned for the rest of the EU in accordance with new directive from 2004 (part which concerns herbal products) - from 1 May 2011 all herbal products in the UK must be licensed or prescribed by a registered herb practitioner. This is connected with the concern over adverse events in these products.

PIM – Innovative Solution for Ensuring Consistent and High-Quality Product Information

EMA (ex EMEA) is performing a pilot phase of what is known as a Product Information Management system (PIM).

It is about interactive IT interface for the submission, review and corresponding update of the product information documents (SmPC, PIL and Labelling) in all 3 community procedures: Centralized, DCP and MRP and for the national procedure as well.

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