Letter: From Roy A. Nierenberg, COWPS, to FDA

by Roy A. Nierenberg on September 26, 1975
by Roy A. Nierenberg

Dear Sir or Madam:

On June 13, 1975, the Food and Drug Administration (“FDA”) issued proposed regulations in the above dockets concerning conditions for marketing human drugs, drugs for human use, procedures for determining in vivo bioavailability of drug products, and procedures for establishing bioequivalence requirements. Notice of these proposed regulations appeared in the Federal Register of June 20, 1975, (40 Fed. Reg. 26142-26171). The time for filing comments in each of these dockets was set at or extended to September 19, 1975. Through discussions with Sam D. Fine, Associate Commissioner for Compliance, FDA, the Council on Wage and Price Stability (“Council”) was permitted to file comments in these dockets on September 26, 1975. We request that this letter be included with the comments in each of the above dockets…

 View Complete Document as PDF    Share Share    Print Print    Email Email

Previous post:

Next post: