US FDA's 2011 guidance documents round-up

By Gareth Macdonald

- Last updated on GMT

Related tags Draft guidance Pharmacology Fda

US FDA's 2011 guidance documents round-up
The US Food and Drug Administration (FDA) will soon start asking drugmakers to play a greater role in guideline development. Before that process begins takes a look at the documents published by the agency in 2011.


The US Food and Drug Administration (FDA) began the year by publishing new draft guidance that looked at the size of beads used​ in sprinkle-based drug delivery systems – see our coverage​. The agency finished the month with some new thoughts on process validation.

February saw the it issue draft guidance on the best approaches to conducting pharmacoepidemiologic safety studies​, publish a revised draft of its distribution requirements for REMS data​ (updated in November) and roll of draft guidance on the most effective ways of conducting pharmacogenomics in clinical trials​.

In March the FDA had costs and quality on its agenda. First under the agency’s microscope were biological products and specifically user fee waivers, reductions and refunds​ which were discussed in a new draft document. New draft guidance on manufacturing practices for beta-lactam antibiotics​ followed just a day later.

April was an even busier month for the FDA, with new guidelines on post-marketing studies​, institutional review boards​ (IRB) and on making changes to product safety information labelling and leaflets​.


The summer months were somewhat quieter for the FDA. In May the agency focused on oral delivery formulations for liquid OTC drugs​ and bioequivalence data for ANDAs​. It also issued draft guidance on financial disclosure requirements for clinical trial investigators​.

June saw the publication of the organisation’s Q11 draft guidance on the development and manufacture of drug substances​ to assist drugmakers in the development of the most effective commercial manufacturing processes. The agency also revised its guidance on dissolution testing​.

In July the FDA did not publish any drug manufacturing-related guidance documents.

August - in contrast - proved to be a busy month with documents covering the production of drugs used in radiopharmaceutical imaging​, the use of biomarkers​ and residues in transdermal delivery devices​ (draft). The FDA also published draft guidance on oversight in clinical trials​.


September saw the FDA set out its position on unapproved drugs on the market​, discuss how drugmakers should assess the risk of reproductive and developmental toxicities​, update on user fees for biologics producers​ and tell firms seeking OTC status what information they need to provide​.

In October the FDA’s moved on to provide information warning information required for biologics products​ and advice on the use of physical markers on oral dosage forms to combat counterfeiting​,


November began with a publication of a Q&A document on Q8, Q9 and Q10​, specifically focused on ways the drug industry can meet such guidelines. Next the FDA issued a medication guide discussing distribution requirements and inclusion in REMS​.

The agency finished the month with guidance on the measurement of the toxicity risk posed by radiopharmaceuticals​.

No final guidance documents were published in December. Instead the FDA issued three draft documents, covering: the classification of pharmaceutical co-crystals​; how drugmakers should respond to requests for ‘off-label’ prescribing information​; and the use of histology in biomarker studies​.

Related topics Bio Developments

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