FDAnews Announces: Drug GMP Report — Drugmakers Win Four-Month Reprieve from Product Tracing Requirement

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For over 20 years, drug manufacturers have relied on Drug GMP Report for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation — information drugmakers need to stay in compliance. Each monthly issue brings subscriber the latest on FDA enforcement trends and warning letters, track and trace developments, international regulations and more.

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The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information.

Drug supply chain trading partners such as manufacturers, wholesale distributors and repackagers initially had been required to start capturing and passing on details about their products on Jan. 1.

However, in guidance published Dec. 24, the FDA says firms along the supply chain that don’t capture and pass on product history and other information during the first four months of this year will not face any sanctions.

The decision stems from industry concerns that some parties in the supply chain aren’t ready to comply with the track-and-trace requirements, and that unforeseen complications with the tracing requirements could disrupt the supply chain and impact patient access, the FDA says.

For over 20 years, drug manufacturers have relied on Drug GMP Report for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation — information drugmakers need to stay in compliance.

Each monthly issue brings drugmakers the latest on FDA enforcement trends and warning letters, track and trace developments, international regulations and more and highlights:

  •     The latest on inspection hot spots
  •     Certification procedures
  •     Electronic data requirements
  •     Evolving trends in drug GMP enforcement

Plus, subscribers get links to critical documents such as draft and final guidances, Form 483s, warning letters, proposed rules, full text of proposed legislation and many more.

Order now and pay just $895, a savings of $150 of the regular one-year price pf $1,045.

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FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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