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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Monday, 23 May 2022

Improving Microbiological Control Of Non-Sterile Pharmaceuticals: Unlocking The FDA Guidance

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  The document is the first time that the FDA has pieced together a compliance framework for non-sterile medicines, and, in some ways, the...
Sunday, 8 August 2021

FDA updates its database about all licensed biological products

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  The FDA has recently updated the “Purple Book” — a database containing information about all licensed biological products — new additions ...
Sunday, 17 January 2021

Useful FDA links

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The following links relating to the U.S. Food and Drug Administration (FDA) may be of interest to readers.   FDA Home Page: http://www.f...
Thursday, 3 December 2020

FDA ANDA Submissions

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  The U.S. FDA has issued a new guidance document ‘ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved AND...
Wednesday, 18 November 2020

Geriatric information in human prescription

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  New FDA draft guidance has been issued, titled ‘Geriatric information in human prescription drug and biological product labeling’ The dra...
Sunday, 25 November 2018

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration

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FDA has issued new draft guidance: “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for...
Saturday, 3 March 2018

FDA: Gluten and drug products

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A new document from the U.S. Food and Drug Administration (FDA): This guidance is intended to convey to drug manufacturers FDA’s recom...
Tuesday, 24 October 2017

50+ FDA acronyms that matter to your business

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The Vaisala Measurement & Monitoring Program is offering a list of useful FDA acronyms. For further details see: Vaisala . ...
Sunday, 13 August 2017

FDA unveils plan to eliminate orphan designation backlog

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U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and e...
Friday, 31 March 2017

Takeaways From The FDA's Revised Quality Metrics Guidance

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On November 23, 2016, the Food and Drug Administration (FDA) published a revised draft guidance for Submission of Quality Metrics Data...
Thursday, 2 March 2017

European and US regulators agree on mutual recognition of inspections

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Important news for those who work in organizations that regularly receive both U.S. FDA and European medicines agency inspectors. This ha...
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Monday, 19 September 2016

Compounded Drug Products That Are Essentially Copies

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U. S. FDA has produced a draft guidance document titled “Compounded Drug Products That Are Essentially Copies of a Commercially Availa...
Tuesday, 26 July 2016

FDA - Product Design to Minimize Medication Errors

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The U.S. Food and Drug Administration has produced a new guidance for industry of interest. It is titled “Safety Considerations for Pro...
Sunday, 10 July 2016

FDA Drug Regulation Procedure

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The Food and Drug Administration (FDA) has the highest responsibility of regulating the safety of drugs and other medicines sold in th...
Tuesday, 31 May 2016

FDA issues recommendations to reduce the risk of Zika virus transmission

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The U.S. Food and Drug Administration  (FDA) has issued recommendations to reduce the risk of Zika virus transmission by human cell an...
Friday, 22 April 2016

FDA - Data Integrity and Compliance With CGMP

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The U.S. Food and Drug Administration (FDA) has released an important draft guidance for industry. the title is: "Data Integrity a...
Sunday, 7 February 2016

Why it is Imperative that the FDA Oversee Lab Developed Tests

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What are Laboratory Developed Tests (LDTs)? These are artificial diagnostic tests that are constructed and used in laboratories to de...