The Firm welcomes the addition of Atty. Kathleen May O. Clareza as among its associates. Prior to joining BCCS Law, Atty. Clareza was a Special Investigator III of the Legal Department of the Food and Drug Administration (FDA). As part of the legal team of the FDA, her responsibilities included, among others, the enforcement of the rules and regulations of the said agency. Being a member of the legal team, likewise, exposed her to the different centers of FDA. Her previous stint with the FDA boosts the FDA practice of the Firm. The Firm’s FDA practice has been thriving in recent years and the intimate knowledge of Atty. Clareza of relevant FDA rules and regulations will be instrumental to the Firm’s FDA related advice and services.
The FDA recently issued Guidelines on Product Recall of health products, placing overall responsibility of conducting product recalls with the Market Authorization Holder (MAH). In particular, MAHs are responsible for providing an appropriate product recall strategy and implementing the same. The Guidelines also created a Product Recall Committee whose principal functions are to review “triggers” for product recall, issue recall resolutions and monitor recall implementation.