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FDA: Updated CDER List for 2016 Guidance Documents

On 8 August 2016, the U.S. Food and Drug Administration (FDA) updated the list of new and revised draft guidances CDER is planning to publish until the end of this year.

The following documents are listed under the category “Pharmaceutical Quality /Manufacturing Standards (CGMP)”:

  • Data Integrity and Compliance with CGMP
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
  • Field Alert Report Submission
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
  • Submission of Quality Metrics Data; Revised Draft (newly added)

The related category “Pharmaceutical Quality/CMC” lists 16 additional guidances, inter alia on Microbiological Quality Considerations in Non-sterile Drug Product Manufacturing or a Technical Conformance Guide for Quality Metrics. Newly added in this category is the guidance on Elemental Impurites in Drug Product.

If you are interested to take a look at the full list of guidances, please click here.

Source:

FDA: CDER List August 2016

 

 

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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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