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Regulatory requirements for supplemental applications: the "grey" area.

Personeus GR. Personeus GR. J Parenter Sci Technol. 1989 May-Jun;43(3):114-6. J Parenter Sci Technol. 1989. PMID: 2732850 No abstract available.

Drug regulation.

Gross M. Gross M. Nature. 1990 Jun 21;345(6277):657. doi: 10.1038/345657c0. Nature. 1990. PMID: 2359442 No abstract available.

FDA, OSHA, and EPA regulation of the recombinant DNA technology.

Korwek EL. Korwek EL. J Parenter Sci Technol. 1982 Nov-Dec;36(6):251-5. J Parenter Sci Technol. 1982. PMID: 7161657 No abstract available.

Bioavailability and bioequivalence requirements: abbreviated applications. Final Rule.

Food and Drug Administration, HHS. Food and Drug Administration, HHS. Fed Regist. 2002 Dec 19;67(244):77668-75. Fed Regist. 2002. PMID: 12492102 Free article.

Opioid peptides as drug products: FDA regulatory requirements.

Hoiberg CP, Rapaka RS. Hoiberg CP, et al. NIDA Res Monogr. 1986;70:385-404. NIDA Res Monogr. 1986. PMID: 3093882 No abstract available.

FDA industry relations, a fresh approach.

Byers TE. Byers TE. J Parenter Sci Technol. 1983 May-Jun;37(3):105-6. J Parenter Sci Technol. 1983. PMID: 6688270 No abstract available.

Parenteral Drug Association response to the FDA compliance policy guide, #7132a.13, entitled, "Parametric release--terminally heat sterilized drug products".

[No authors listed] [No authors listed] J Parenter Sci Technol. 1988 Jul-Aug;42(4):105. J Parenter Sci Technol. 1988. PMID: 3183862 No abstract available.

PDA presentation at FDA Open Conference on Sterile Drug Manufacturing. Parenteral Drug Association.

[No authors listed] [No authors listed] J Pharm Sci Technol. 1994 Jan-Feb;48(1):4-6. J Pharm Sci Technol. 1994. PMID: 8004417 No abstract available.

[International interdependence of new German pharmaceutical laws].

Hasskarl H. Hasskarl H. Monogr Gesamtgeb Psychiatr Psychiatry Ser. 1978;19:61-77. Monogr Gesamtgeb Psychiatr Psychiatry Ser. 1978. PMID: 714040 German. No abstract available.

The regulatory role of the United States Food and Drug Administration.

Ortiz EM. Ortiz EM. J Reprod Med. 1972 Apr;8(4):205-6. J Reprod Med. 1972. PMID: 5029971 No abstract available.

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