FDA slaps Mexico’s Prosana with warning letter – In need of compliant quality solutions?
January 11, 2018
By Neozene

Five months after blocking the products of Prosana Distribuciones from the U.S., the FDA has issued a warning letter for the Mexican company. The letter, which was issued December 18, follows an import alert for the company issued in August after the FDA found out that employees had not been testing APIs and admitted they had falsified some batch records for the OTC products it was shipping to the U.S. The warning was the result of an inspection in March 2017 at the Mexico City facility and followed some back

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US Regulators Refine Least Burdensome Provisions for Medical Device Oversight
January 3, 2018
By Neozene

Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. FDA’s latest draft guidance on Least Burdensome Provisions will replace guidance on the topic issued in 2002; recently passed US laws including the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act expanded upon Least Burdensome Provision concepts and principles, necessitating revised guidance. Broader scope of applicability The updated FDA Least Burdensome Provisions apply across all major FDA medical device regulatory activities and processes, including 510(k)

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FDA opens door to multiarm, multicompany clinical trials
December 19, 2017
By Neozene

The FDA has outlined how developers of drugs targeting rare pediatric diseases can streamline their clinical development programs by collaborating. Officials want drug developers to consider multicompany clinical trials to test multiple candidates in single trials, thereby cutting the number of patients who need to receive placebos. Using Gaucher disease as an example, the FDA’s draft guidance (PDF) shows how companies can team up and run multidrug clinical trials. These studies would enable multiple experimental candidates to be compared against a single control group, increasing the proportion of patients in active arms.

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