References
- Food and Drug Law. Richard M. Cooper, 1991; 249–252
- Food and Drug Law. Case Materials, Merrill, Hutt, 1980; 370–378
- NDAs for Duplicative Drug Products of Post-1962 Drugs. FR 1981; 46: 27396
- 1984; 98–417, Pub. L. No.
- The Big Lie about Generic Drugs. Consumer Reports 1987; 52(8)480–487
- Report of the Bioequivalence Task Force on Recommendations from the Bioequivalence Hearing Conducted by the Food and Drug Administration. FDA January, 1988
- Ander G, Rumore M M, Torre G M, Hyman L. Major Consequences of the Generic Drug Scandal of 1988. Regulatory Affairs 1994; 6: 137–159
- New Drug and Abbreviated New Drug Applications; Preapproval Inspection Requirements. Final Rule. FR 1993; 58: 47340–47352
- Retention of Bioavailability & Bioequivalence Testing Samples. Final Rule. FR 1993; 58: 25918–25928
- Generic Drug Enforcement Act of 1992. 1992; 102–282, Pub. L.
- Civil Money Penalties: Biologies, Drugs, and Medical Devices. Proposed Rule. FR 1993; 58: 30680–30689
- Abbreviated New Drug Applications. Final Rule. FR 1992; 57: 17950–18001
- July, 1987, Understanding and Preparing ANDAs. Speech given by David Rosen at RAPS Seminar
- Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes (SUPAC) Notice. FR 1995; 60: 61638
- Generic Drugs: A New Era. Speech Given by Roger Williams at RAPS Annual Meeting. September, 1991