U.S. Regulatory Reporter

This publication, the U.S. Regulatory Reporter Newsletter, is a monthly newsletter providing regulatory information for the pharmaceutical, medical and allied industries, and has been the primary source of FDA news for hundreds of regulatory and drug development professionals at pharmaceutical, financial, legal, and related companies worldwide. From CANDAs to NDA Days, and from emerging drug access programs to innovative vehicles for drug export, the U.S. Regulatory Reporter covers the FDA like no other periodical. Each monthly issue provides you with insights and in-depth articles, in addition to executive summaries of all FDA actions, including new proposed and final regulations, speeches by FDA officials, new product approvals, advisory committee meetings, and more.

Biologics and Biotech Regulatory Report

Each issue of the U.S. Regulatory Reporter includeds a special supplement specifically dedicated to CBER's regulation of biologics and biotechnology products: the Biologics and Biotech Regulatory Report. From the new "managed review " process to the electronic lot release program, the Biologics and Biotech Regulatory Report dissects CBER's policies and procedures to help you understand how they affect your company and products. We also keep you up-to-date on CBER's agenda for CAPLARs, and their latest initiatives involving tissue banking, cell and gene therapies, and AE reporting. Because these issues are critical to your success, the Biologics and Biotech Regulatory Report provides you with in-depth analyses of the issues, a staff of professionals dedicated to answering your informational needs, and monthly access to the insights and advice of officials and staffers throughout CBER.

Also included with the U.S. Regulatory Reporter and the Biologics and Biotech Regulatory Report...

Regulatory Review

The Regulatory Review section provides summaries of regulatory final rulings, proposals, and other actions and announcements made by the FDA and other regulatory agencies. The entries are compiled from official U.S. government publications, news releases, meetings, and our staff's interactions with CDER and CBER officials. The Regulatory Review provides you with a running status report of the FDA's activities that affect you. You can easily scan through the rulings and proposals for the ones that most directly affect you. What's more, you can easily obtain the full text of many of the Regulatory Review summaries as they appear in official government publications, by simply contacting the U.S. Regulatory Reporter staff. With the U.S. Regulatory Reporter, it's like having a regulatory intelligence - gathering department at your disposal.

Available for the following regions:

U.S. Regulatory Reporter Newsletter for Addresses in North America - This publication, the U.S. Regulatory Reporter Newsletter, is a monthly newsletter providing regulatory information for the pharmaceutical, medical and allied industries. Includes 1 year subscription. $395.00

U.S. Regulatory Reporter Newsletter for Addresses in Europe - This publication, the U.S. Regulatory Reporter Newsletter, is a monthly newsletter providing regulatory information for the pharmaceutical, medical and allied industries. Includes 1 year subscription and shipping costs to Europe. $425.00

U.S. Regulatory Reporter Newsletter for International Addresses Outside of Europe - This publication, the U.S. Regulatory Reporter Newsletter, is a monthly newsletter providing regulatory information for the pharmaceutical, medical and allied industries. Includes 1 year subscription and shipping to international addresses other than Europe. $445.00