FDA Publishes Guidance Agenda for 2013

Written by Bob Pollock • January 31, 2013

Today, the FDA published an agenda of the Guidance documents it intends to publish in 2013.  This is the FDA wish-list of new or revised Guidance documents and, as history has borne out, while many of the documents will be issued in this 2013 period, many will also die on the vine or suffer significant delays in publishing.  Below are some Guidance documents of interest from the 59 cited on the Agency’s list; - to see the entire list please click here.

• Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration -  FDA appears to be ready to revise two long-standing general gGuidance documents and combine them into one document.  Keep your eyes open for this one as it will likely have some interesting changes.
• Size and Physical Attributes of Generic Tablets – The Office of Generic Drugs (OGD) placed this Guidance on the back burner about a year and a half ago, but now it appears to be moved to center stage.  Depending on its content, this could have an impact on products currently pending at OGD or under development at firms
• Immunogenicity Assessment for Therapeutic Protein Products - Interesting timing of such guidance with the advent of biosimilars!
• Control of Highly Potent Compounds (OMPQ) – Could this document give us the answers on new categories of products that must be manufactured in separate facilities or contained areas?
• Pre-Launch Activities Importation Request (PLAIR) - Finally!
• Safety Considerations in Product Design to Minimize Medication Errors – This Guidance, combined with the Guidance on size and shape of generic products, should provide the Industry with a good blueprint to help avoid running afoul of FDA’s concern relative to confusion in the marketplace.
• Drug Names and Dosage Forms – Listed under Labeling Guidance, this could provide a view into where the FDA is going relative to drug names and the establishment of new dosage forms.  We expect some standardization and perhaps a collapse of some common dosage forms, or at least some direction on when a new dosage form designation would be appropriate.Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and Cosmetic Act – Certainly a controversial issue that has been in the news on almost a daily basis.  Will the Agency set new boundaries on its Safe Harbor provisions?  Will Congress act before the issuance of this guidance and drive the Agency’s position?

The Industry should closely monitor the FDA activities relative to the publication of theses Guidance documents so they can provide comment to the Agency on the draft versions prior to finalization.  Even if the document is issued in final form, the Agency will entertain and consider comments relative to their positions taken in the Guidance.  

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