Abstract
Following are comments prepared by PDA on three draft regulatory documents all relating to stability for post-approval changes, new dosage forms and related issues. The comments on SUPAC-IR and ICH Q1C were submitted to FDA on February 10, 1995. The comments on the December 12, 1994 draft guideline were submitted on March 10, 1995. The documents have different sources and content, however there is some overlap between the three. Readers may wish to peruse the table attached to the March 10, 1995 PDA comments for a graphic analysis of the contents of the three documents. Readers are cautioned that these comments are based on draft proposals by FDA and/or the International Conference on Harmonization. More recent drafts may be available. Copies of all three documents are available from PDA (SUPAC-IR: Document #FDA 79; ICH Q1C: #FDA 93; December 12, 1994 guideline: #FDA 77). See the PDA Letter or contact the PDA staff for additional information. Further clarifying comments can be found in the January, March and April 1995 issues of the PDA Letter. Staff contact is James Lyda. PDA expresses thanks to the working group which drafted the comments on very short notice: Raymond Shaw, Jr. Ph.D., Merck {now of Wyeth-Ayerst) (Chair); Robert Barraza, Burroughs Wellcome; Fred Gustafson, Abbott; Paulette Kosmoski, and Russell Madsen and James Lyda, PDA.
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