...44838, Sept. 29, 1978; 47 FR 44071, Oct. 5, 1982; 47 FR 50211, Nov. 5, 1982; 51 FR 15607, Apr. 25, 1986; 55 FR 11014. Mar. 26, 1990] § 601.26 Reclassification...of Food and Drugs (Commissioner) has proposed under § 601.25(f)(3), or the Commissioner has finally decided under § 601.25(g) that available data are...

...under §601.26 of this chapter. The superseded text is included for the convenience of the user only. §601.26 Reclassification procedures to determine...of Food and Drugs (Commissioner) has proposed under §601.25(f)(3i. or the Commissioner has finally decided under §601.25(g) that available data are insufficient...

...Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997; 64 FR 56452, Oct. 20, 1999] §601.26 Reclassification procedures to determine...have been classified into Category IIIA. A Category §601.26 of this chapter. The superseded text is included for the convenience of the user only. §601.26...

...50211, Nov. 5. 1982; 51 FR 15607, Apr. 25, 1986; 55 FR 11014. Mar. 26. 1990te §601.26 Reclassiflcation procedures to determine that licensed biological products...biological products that have been classified into Category IHA. A Category nIA biological product is one for which an advisory review panel has recommended under...

...under §601.26 of this chapter. The superseded text is included for the convenience of the user only. {601.26 Reclassification procedures to determine that...use. This regulation establishes procedures for the reclasslfication of all biological products that have been classified into Category TTTA. A Category...

...safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. 601.26 Reclassification procedures to determine that...prescribed, recommended, or suggested conditions of use. 601.27 Pediatric studies. 601.28 Annual reports of postmarketing pediatric studies. 601.29 Guidance...

...Products in short supply; initial manufacturing at other than licensed establishment. 601.25 Review procedures to determine that licensed biological products...prescribed, recommended, or suggested conditions of use. 601.26 Reclassificatlon procedures to determine that licensed biological products are safe, effective,...

...revocation of licenses. [42 FR 4718, Jan. 25, 1977, as amended at 61 FR 24233, May 14, 1996] §601.25 Review procedures to determine that licensed biological products...prescribed, recommended, or suggested conditions of use. For purposes of reviewing biological products that have been licensed prior to July 1, 1972, to determine...

...under §601.26 of this chapter. The superseded text is included for the convenience of the user only. §601.26 Reclassification procedures to determine...licensed biological products are safe, effective, anal not misbranded under prescribed, recommended, or suggested conditions of use. This regulation...

...procedures for classifying some OTC drugs as generally recognized among qualified experts as safe and effective and not misbranded under prescribed, recommended, or suggested conditions of use. Any OTC drug not conforming to the requirements established for such drugs must be the subject of an...