Jan 17, 2012
By:
Rich Whitworth
Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention.
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Jan 3, 2012
By:
Rich Whitworth
Pfizer and GlaxoSmithKline (GSK) entered into separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis and is one of the leading causes of death in children under the age of five in developing countries.
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Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?
Jan 1, 2012
By:
Rich Whitworth
Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?
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Dec 20, 2011
By:
Rich Whitworth
The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. The initiative will begin in January 2012, according to a jointly issued press release on Dec. 9, 2011, and will enable the two authorities to rely on each other's inspections outcomes instead of conducting inspections in duplicate
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Dec 13, 2011
By:
Rich Whitworth
In an initiative that could signal a new era in private?public partnerships, AstraZeneca will make 22 compounds available for free to medical researchers next year for projects funded by the United Kingdom?s (UK) Medical Research Council (MRC).
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Readers react to the economic turmoil of the past year and look longingly forward to 2012.
Dec 1, 2011
By:
Amy Ritter, PhD, Rich Whitworth
Readers react to the economic turmoil of the past year and look longingly forward to 2012.
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Nov 22, 2011
By:
Rich Whitworth
The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation. Since Annex 16 was introduced in 2001, a number of positive and negative trends have occurred in the pharmaceutical industry. In particular, confusion has arisen over the role of the qualified person (QP), and harmonization of requirements has been lost between member states. The EMA cites several commonly asked questions within the concept paper:
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Nov 8, 2011
By:
Rich Whitworth
The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011.
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Oct 11, 2011
By:
Rich Whitworth
EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.
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