The Lachman Blog

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03
Sep

Compounding Pharmacies – Do You Notice a Trend Developing?

Ever since the meningitis outbreak associated with the products from the New England Compounding Center, the FDA and the States have been taking a closer look at this segment of the industry. So far, in 2013 alone, the FDA has issued 51 Safety Alerts for Human Medical Products, of which 17 (33%) related to sterile pharmacy compounded products and/or laboratories that tested those products for sterility and/or potency. In addition, FDA has taken 54 separate actions against compounding pharmacies in 2013 alone, with only 24 actions taken in the previous 5 years.

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22
Aug

FDA and the EMA (European Medicines Agency) Issue Q&A Document to Communicate Results from Initial QbD Parallel Assessment

On August 20, 2013, FDA and the EMA (European Medicines Agency) published a document entitled, “EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: Lessons learnt and Q&A resulting from the first parallel assessment.”   The Q&A document provides information regarding agreements that were made between the agencies as a result of the first FDA-EMA parallel […]

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