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FDA Asking for Comments on Standards for Tracing Rx Drugs

FDA is establishing a public docket to receive information and comments on the standards needed to comply with the track and trace provisions in Title II of the Drug Quality and Safety Act. A February 20 Federal Register announcement explains that the agency wants to figure out how to confirm that all transaction information, including […]

FDA Begins Secure Supply Chain Pilot

FDA has begun its Secure Supply Chain Pilot Program, which will permit 13 participating companies to import up to five products into the U.S. with an expedited clearance. Announced last August, the pilot is intended to allow the agency to focus its surveillance on shipments that are at higher-risk of adulteration or counterfeiting (IPQ September […]

FDA Implements ICH Photosafety Evaluation Guideline (S10)

In early February, FDA announced its implementation of ICH’s photosafety evaluation guideline (S10). The guideline addresses the toxicity resulting from drug exposure to light. In order to better address safety concerns, a distinction has also been made between phototoxicity and photoallergy.

CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans

The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA)....

IPQ Monthly Update, July/August 2013

The IPQ Monthly Update for July/August 2013 is now available....

NSF-IPEC 363 GMP Standard Will Provide Risk-Based Approach for Auditing and Certifying Excipient Manufacturers

NSF International is working with the International Pharmaceutical Excipients Council (IPEC) and FDA to turn the IPEC excipient GMPs into a risk-based, certifiable standard with global applicability by the end of 2013, as recognition of the importance of excipient control continues to grow....

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

U.S. and Five Other Countries Await Listing Decision Under EU’s Falsified Medicines Directive

The U.S. is among six countries with applications pending at the European Commission (EC) to be listed as a third country with GMPs equivalent to those in force in the EU, which allows continued export of active pharmaceutical ingredients (APIs) into the EU without a company-specific certification under the terms of the EU’s Falsified Medicines […]

API Switch in OTC Cough Syrup Kills at Least 60 in Pakistan and India

The World Health Organization (WHO) reported in an “information exchange system alert” issued in late January that cough syrup manufactured in India using an incorrect raw material has resulted in the deaths of at least 60 people in Pakistan and India. The incidents occurred in November and December and were linked to cough syrup produced […]
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