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April 17, 2013
FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
April 02, 2013
Draft guidance combines and supersedes previous guidance documents.
March 21, 2013
The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.
February 19, 2013
The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.
February 05, 2013
FDA has released a list of more than 50 guidance documents planned for 2013.
February 02, 2013
Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.
January 29, 2013
Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.
January 15, 2013
FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance
January 08, 2013
Eli Lilly expects overall revenue growth in the coming year.
January 01, 2013
The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.