Latest FDA Guidance on Clinical Investigations

 Periodically, the U.S. Food and Drug Administration (FDA) publishes guidance to industry on various matters under its regulatory jurisdiction.  Typically, the agency would publish a draft copy and request input from the American public during a specific period.  Upon the expiration of the comments period, the agency publishes a final version of the guidance, which [...]

FDA’s Final Guidance on Investigator Responsibilities

On October 29, 2009, the U.S. Food and Drug Administration (FDA) issued a guidance that provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device.  The guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility to supervise [...]

FDA Guidance for Pharmaceutical Industry on Melamine Contamination

On August 6, 2009,  the U.S. Food and Drug Administration (FDA) issued a guidance for specific pharmaceutical ingredients used in the manufacture or preparation of drug products to be tested for melamine.  The guidance also recommends the use of FDA-published methods (used to detect the presence of melamine in food proteins) for this testing. Melamine is a [...]

Fighting Counterfeit Drugs – FDA Draft Guidance

Counterfeiting is a growing global problem.  The infiltration of counterfeit drugs into mainstream supply chain in many countries poses a direct threat to consumer health, worldwide.  The U.S. is no exception.   Counterfeit products fall under the classification of intellectual property rights (IPR) violations.  The U.S. Customs and Border Protection, reports that the domestic value of [...]