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Research Article

Recent Changes in U.S. Food and Drug Law: Implications for Drug Development

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Pages 739-802 | Published online: 20 Oct 2008

BIBLIOGRAPHY

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  • Federal Register Feb. 22, 1985; Vol. 50: 7452–7456, #36, - Effective Date (7)
  • Regulatory Affairs Management in the Pharmaceutical Industry. Draft Guidelines For the Preparation of NDA, East Brunswick, N.J. Sept. 8–10, 1986; 6, Barb Matlosz Section E
  • Reg. Affairs Mgt. in the Pharm. Industry. East Brunswick, N.J. Draft Guidelines For the Preparation of NDA, Barb Matlosz - Section E. Sept 8–10, 1986; 5
  • Ibid. 44
  • Ibid. 18
  • Federal Register Feb. 22, 1985; Vol. 50: 7457, #36
  • Drug Development and Industrial Pharmacy 1985; 11(5)1001–1018, “Aspects of Regulatory Requirements in Industrialized Countries”, Anthony S. Anginoli, Schering-Plough Corporation, Kenilsworth, N. J., p. 1003, 1007
  • Federal Register Feb. 22, 1985; Vol. 50: 7459–60, #36
  • Federal Register Feb. 22, 1985; Vol 50: 7460, #36, (29), (314.50(d)) (2)
  • Federal Register Feb. 22, 1985; Vol. 50(No. 36)7460–1, (Section 314.50 (d) (3)) Human Pharmacokinetics and Bioavailability
  • Federal Register Feb. 22, 1985; Vol. 50: 7462, #36, Clinical Data Section – General (324.50 (d) (5)
  • Federal Register Feb. 22, 1985; Vol. 50: 7468, #36, Adequate and Well-Controlled Studies (314.126)
  • Federal Register Feb. 22, 1985; Vol. 50: 7462, #36, Clinical Data Section - General (314.50 (d) (5)) #38
  • Federal Register Feb. 22, 1985; Vol. 50: 7453, #36, Foreign Data Section – Highlights of the Final Rule (d5)
  • Wall Street Journal
  • Federal Register Feb. 22, 1985; Vol. 50: 7462, #36, Safety Update Reports (314.50 (d) (5) (vi) (b))
  • Regulatory Affairs Management in the Pharamaceutical Industry. Sept. 8–10, 1986; 5, East Brunswick, NJ, Section K - Barbara Kostiuk
  • Ibid. 6, Section K - Barbara Kostiuk
  • Ibid.
  • Ibid. 8
  • Regulatory Affairs Management in the Pharmaceutical Industry. Sept. 8–10, 1986; 31–43, East Brunswick, NJ, Section K - Barbara Kostius
  • Regulatory Affairs Management in the Pharmaceutical Industry. Op. cit. Feb. 22, 1985; Vol. 50: 7471, #36, Section K - Barbara Kostiuk, p. 45, pp, 7, 9, 11, 13. Federal Register, (D23), Requirements for 15-day alert
  • Ibid.
  • Ibid.
  • Federal Register Feb. 22, 1985; Vol. 50: 7485, (D37). #36, Approvable and Not Approvable Letters (314.50/324.120)
  • Ibid.
  • Ibid.
  • Federal Register Feb. 22, 1985; Vol. 50: 7460, #36, Human Pharmacokinetics and Bioavailability Section - (314.50 (d) (3)). Part 320 - NDA rewrite (D68)
  • Federal Register Feb. 22, 1985; Vol. 50: 7478–9, #36, Time Framer for Reviewing Applications (314.100), #97, 98
  • Federal Register Feb. 22, 1985; Vol. 50: 7480–1, #36, Dispute Resolutions (Section 314.103)
  • Ibid. 7478–9
  • Regulatory Affairs Management in the Pharmaceutical Industry. Sept. 8–10, 1986; 1–2, East Brunsvick, NJ. Follow Up Submissions - Barbara Matlosz (Section H)
  • Ibid. 2–3
  • Ibid.
  • Reich, Jack W., Daniel Hilleman E. A Geocentric Approach to Pharmacetuical Research and Development and Drug Regulatory Affairs. Clinical Research Practices & Drug Regulatory Affairs 1985; Vol. 3(1)1–22

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