Food & Drug Bulletin

Dear Reader:

International Harmonization means different things to the FDA regulated community. Makers of pharmaceuticals and biologics, have been searching for a single application that can be filed for approval with any of the major world regulatory authorities.

What has emerged - the "Common Technical Cocument" (CTD) - will be under review in San Diego in November at the fifth meeting of the International Conference on Harmonization (ICH).

While ICH technically applies only to the U.S., Japan and the EU, all industries should be review the CTD. FDA has made clear that the final CTD will "represent FDA's current thinking." The agency will expect firms to adopt the requirements into their submissions to FDA in the near future.

Not only traditional research-based drug firms will be expected to conform to the CTD. The draft CTD shows it will also apply to applications for "biotechnology-derived products" and, with unspecified "appropriate modifications," to abbreviated or abridged applications.

If the CTD will impact your filings, you have an opportunity to provide your comments to the FDA (formally by Sept. 30) or at the ICH conference.

We hope to see you at the conference.

Sincerely,

Michael Swit

Of Counsel

Articles In This Issue

Court of Appeals Overturns Decision on Phamanex's Cholestin

Appeals Court Strikes Down HACCP-Based Inspections

Understanding Electronic Signatures Law

Uniform Electronic Transactions Law Enacted

Food and Drug Practice in Brussels Publishes Article on EU Regulation of Drugs/Devices

Indemnification Agreements in Chemical Trials

GAO Weighs in on Reprocessing of Single Use Devices

FDA Issues ICH GMP Draft Guidance for Active Pharmaceutical Ingredients

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