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Pubmed for Handhelds

PUBMED FOR HANDHELDS

Journal Abstract Search

109 related items for PubMed ID: 1522442

  • 1. PDA response. FDA proposal to amend cGMP's entitled--use of aseptic processing and terminal sterilization in the preparation of sterile pharmaceuticals for human and veterinary use. Parenteral Drug Association.
    J Parenter Sci Technol; 1992; 46(3):65-8. PubMed ID: 1522442
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  • 2. An FDA update on GMP's for aseptic processing.
    Fry EM.
    J Parenter Sci Technol; 1985; 39(4):154-7. PubMed ID: 3928863
    [No Abstract] [Full Text] [Related]

  • 3. PDA presentation at FDA Open Conference on Sterile Drug Manufacturing. Parenteral Drug Association.
    J Pharm Sci Technol; 1994; 48(1):4-6. PubMed ID: 8004417
    [No Abstract] [Full Text] [Related]

  • 4. Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice.
    Fed Regist; 1998 Jan 28; 63(18):4272-3. PubMed ID: 10177326
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  • 9. Helpful tips for extralabel drug use: record keeping, record access, and product labels. The FDA-Center for Veterinary Medicine and the American Veterinary Medicine Association.
    J Am Vet Med Assoc; 1998 Mar 01; 212(5):666-7. PubMed ID: 9556375
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  • 10. PDA's response to FDA's "Guideline on sterile drug products produced by aseptic processing".
    Akers JE, Agalloco JP, Carleton FJ, Korczynski MS.
    J Parenter Sci Technol; 1988 Mar 01; 42(4):114-7. PubMed ID: 3183865
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  • 11. FDA update on aseptic processing guidelines.
    Fry EM.
    J Parenter Sci Technol; 1987 Mar 01; 41(2):56-60. PubMed ID: 3598820
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  • 13. Sterility requirement for aqueous-based drug products for oral inhalation. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 May 26; 65(103):34082-9. PubMed ID: 11010719
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  • 14. Regulatory issues of parenteral equipment and systems.
    Avallone H.
    J Parenter Sci Technol; 1988 May 26; 42(3):89-93. PubMed ID: 3216268
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  • 15. Good manufacturing practices and clinical supplies.
    Levchuk JW.
    J Parenter Sci Technol; 1991 May 26; 45(3):152-5. PubMed ID: 1886044
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  • 17. Biological technical amendment--FDA. Final rule; technical amendment.
    Fed Regist; 1992 Apr 02; 57(64):11263. PubMed ID: 10118456
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  • 18. Current FDA policy on use of human-labeled drugs in animals.
    Teske RH.
    J Am Vet Med Assoc; 1993 May 15; 202(10):1632-3;discussion 1634. PubMed ID: 8514570
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  • 20. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 1999 Dec 03; 64(232):67720-63. PubMed ID: 11010665
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