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September 02, 2012
PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.
Ties between the biotechnology industry and university research are crucial.
International trade can be great for business, but breaking border laws can put one in hot water.
September 01, 2012
Regulators in both the EU and the US have attempted to stimulate paediatric-drug development with incentives offering extended periods of patent protection, but are these actions having the desired effects?
Policymakers must balance fundamental issues involving access to medicines and pricing.
August 02, 2012
Manufacturers willing to report bad news about the supply can help reverse the shortage trend.
New law provides FDA with the resources it needs to safeguard drug supply chain.
Meticulous system configuration can prevent machines from taking over.
August 01, 2012
Germany has shifted from a market where the pharmaceutical industry could enjoy considerable pricing freedom to a sensitive market influenced by cost-containment policies.
July 18, 2012
The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.