Feb. 10, 2012 | Vol. 4 No. 6
Stronger Google barriers against online pharmacy ads — part of a settlement with the Department of Justice (DoJ) — may strengthen the legal pharmaceutical supply chain and thwart counterfeiters.
Improper or lax training can be an Achilles heel for any drug- or devicemaker.
Akzo Nobel Chemicals’ Mexican manufacturing facility was placed under an import alert after it failed to investigate and prevent shipment of contaminated products.
Bristol-Myers Squibb (BMS) and AstraZeneca (AZ) have received a complete response letter for diabetes drug dapagliflozin.
The FDA has handed ViroPharma a complete response letter (CRL) on its industrial scale manufacturing supplement for hereditary angioedema (HAE) drug Cinryze, citing concerns about a portion of the cleaning validation.
A Florida surgical lamp company has received a warning letter over GMP violations and its lack of premarket approval (PMA) for one product line.
Genzyme can begin manufacturing Fabry disease drug Fabrazyme at its Framingham, Mass., plant after winning FDA approval for the facility.
Drugmakers should prepare for law enforcement agencies to expand their reach and focus more on R&D practices and trial conduct in coming years, compliance and legal experts warn.
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