Header graphic for print
Focus on Regulation

Tag Archives: Q&A

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling.  Under the 24-page decree, a federal court enjoined the defendants,

EMA publishes a draft Q&A document for consultation on the environmental risk assessment guidelines

On 26 March 2015, the European Medicines Agency (“EMA”) published a draft Questions and Answers Document (“Q&A Document“) for consultation concerning the EMA’s Guideline on the environmental risk assessment of medicinal products for human use (“EMA Guideline“). The purpose of the Q&A Document is to clarify and harmonise the use of the EMA Guideline. The