Attention All Members with operations in Puerto Rico
The FDA is seeking your assistance in supporting the recovery efforts from Hurricane Maria. The agency would like to communicate with you directly about any product-specific issues related to disruptions caused by the hurricane, including current and ongoing infrastructure needs for manufacturing facilities on the island of Puerto Rico, such as fuel, transport, and communications.
As part of its ongoing efforts to alleviate drug shortages, PDA is assisting the FDA by sharing their request for information regarding the impact of Hurricane Maria on manufacturers and on drug supply.
Please reach out to directly to the FDA via email at: drugshortages@fda.hhs.gov
The issue of drug shortages demands attention and collaboration from everyone involved; from regulators to developers, end users, and patients. PDA is working together with regulators and in collaboration with other industry associations. The complementary contribution by PDA focuses on risk based prevention at a product level. A risk triage approach for proactive management of drug shortage has been developed and will be trained.
PDA’s Contributions
Technical Report No. TR 68: Risk-Based Approach for Prevention and Management of Drug Shortages
PDA Technical Report No. TR 68: Risk-Based Approach for Prevention and Management of Drug Shortages, includes valuable tools to help organizations address the globally significant issue of drug shortages. To ensure these tools are available to all who will benefit from them, PDA is pleased to provide this singular technical report to the public for FREE. PDA Technical Reports are highly valued documents made available for free download to PDA Members or available for purchase at the PDA Bookstore.
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Risk Management Tools
Conferences and training opportunities are being scheduled. For details see:
Additional Resources Relating to the Subject and Project