US FDA's 2011 guidance documents round-up

Spring​

The US Food and Drug Administration (FDA) began the year by publishing new draft guidance that looked at the size of beads used​ in sprinkle-based drug delivery systems – see our coverage​.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February saw the it issue draft guidance on the best approaches to conducting pharmacoepidemiologic safety studies​, publish a revised draft of its distribution requirements for REMS data​ (updated in November) and roll of draft guidance on the most effective ways of conducting pharmacogenomics in clinical trials​.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 New draft guidance on manufacturing practices for beta-lactam antibiotics​ followed just a day later.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​.

Summer​

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 It also issued draft guidance on financial disclosure requirements for clinical trial investigators​.

June saw the publication of the organisation’s Q11 draft guidance on the development and manufacture of drug substances​ to assist drugmakers in the development of the most effective commercial manufacturing processes.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 The FDA also published draft guidance on oversight in clinical trials​.

Autumn​

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​,

Winter​

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​.