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November 05, 2013
FDA releases guidance on pulmonary tuberculosis drugs.
November 04, 2013
EMA and FDA publish joint QbD guidance on design space verification.
September 30, 2013
FDA publishes guidance on ANDA submissions.
EMA revises HIV treatment guideline.
September 25, 2013
Boehringer Ingelheim initiates a recall due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler (tiotropium bromide inhalation powder) capsules.
September 18, 2013
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.
September 17, 2013
EMA releases details of restructuring.
September 16, 2013
FDA issues import alert due to cGMP violations at Ranbaxy's facility in Mohali, India.
FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.
September 12, 2013
FDA updates guidance to reflect advances in technology.