DCAT Week 2007 Preview

DCAT Week and 81st DCAT Annual Dinner

SST will be attending DCAT Week once again this year - from March 19 to 22, 2007, at the Waldorf=Astoria in New York City. DCAT Week is one of the pharmaceutical and chemical industry's premiere events, and SST is proud to have attended for more than 50 years.

We cordially invite you to join us in Suite 24M of the Waldorf=Astoria Hotel on Thursday, March 22, 2007 for cocktails and refreshments before and immediately following the annual DCAT dinner. If you would like to arrange a private meeting, please email info@sst-corp.com or call 973-473-4300. We look forward to seeing you there.

Informex USA: Wrap-up
SST enjoyed a successful exhibition at Informex USA this year. We would like to thank all of our customers and supplier partners who stopped by our booth or had a meeting with us. We will be following up with you in person in the very near future.

SST Addresses FDA on Regulatory
Relief for its Suppliers

On February 7, SST's Dr. Arthur Fabian spoke at a public meeting on issues the Food and Drug Administration (FDA) should consider when revising CFR 314.70: Supplements and Other Changes to an Approved Application. Industry trade groups (GPhA, PhRMA and CHPA) also presented at this meeting.

All parties agreed that the regulation should be changed, and a common opinion was that the CBE-0/CBE-30 filing mechanism ought to be eliminated entirely. In his presentation, Dr. Fabian focused on the drug substance and DMF holders (rather than the dosage form) and offered suggestions to address the present deficiencies in this regulation and the guidance through which it is promulgated.

The meeting confirmed that the FDA is serious about revising CFR 314.70, and clearly demonstrated the FDA's willingness to solicit the industry for relevant ideas. SST is pleased to have participated in this process, since a revision would ultimately benefit SST's suppliers.

The meeting agenda, presentations and transcript may be found at: http://www.fda.gov/cder/meeting/cmc.htm.