COMMENT & PRESENTATION DOCUMENTS SUBMITTED TO FDA

  1. Formal comments on the FDA's Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals, IN SEPTEMBER 1997.
  2. In-Process Powder Blend Sampling And Evaluation (And Appropriate In-Process and Final Release Specifications), A WHITE PAPER, JANUARY 1998. [This white paper was submitted to certain key industry and FDA administrators at the 22nd International GMP Conference held in March 1999 at the University of Georgia in Athens, GA; the Agency has reviewed, commented on, and provided a formal response on one of the key issues discussed (in-process mix uniformity testing).]
  3. Formal comment on FDA's proposed 21 CFR 26, Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, And Certain Medical Device Premarket Evaluation Reports Provide By European Community Member State Regulatory Authorities And European Community Conformity Assessment Bodies in May 1998.
  4. Formal comment on FDA's proposed Draft Guidance for Industry on ANDA's Impurities in Drug Substances (.../guidance/2452dft.pdf), Docket: 98D-0777, reopened in Federal Register, 63, of October 19, 1998.
  5. Formal comment on FDA's proposed Draft Guidance for Industry on Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (.../guidance/1212dft.pdf), Docket: 98D-0777, Federal Register, 63(189), 52276-52277, Wednesday, September 30, 1998.
  6. Remarks presented to FDA at DAMA Stakeholder Meeting, Wednesday, 28 April 1999 In Philadelphia, PA,
  7. QUALITY CONTROL AND STATISTICS A GUIDANCE WHITE PAPER, JULY 2001, pp. 87 for 1-day training seminar at FDA's CDER Division of Manufacturing and Product Quality in Rockville, MD.
  8. Initial Remarks To Docket: 03N-0059, Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach, Comment Number: EC ? and ?, Accepted, Volume 1, 01 March 2003.
  9. A Scientific Review of PQRI December 2002 Report, THE USE OF STRATIFIED SAMPLING OF BLEND AND DOSAGGE UNITS TO DEMONSTRATE ADEQUACY OF MIX FOR POWDER BLENDS, A TECHNICAL REVIEW FOR THE FDA, MARCH 2003, pp. 87 (pp. 42 W/O APPENDICES).
  10. Formal initial electronic-submission comments to Docket: 02D-0526 on the Food and Drug Administration's "Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information; Availability," submitted electronically on 3 April 2003, posted to daily dockets on 4 April 2003 submitted pursuant to a request for comments promulgated in FEDERAL REGISTER, 68(18), pages 4219 4220, Tuesday, 28 January 2003.
  11. E-mail Comments to FDA (pat@cder.fda.gov) on Agency's Risk Based Approach to CGMP, submitted 1 March 2003.
  12. E-mail Comments to Docket: 03D-0060: Draft Guidance: Part 11, Electronic Records, Electronic Signatures Scope and Application, 22 March 2003.
  13. E-mail Comments to Docket 03D-0059 A Risk-Based Approach to CGMP, 24 March 2003.
  14. Initial Formal Comment To Docket 02D-0526 Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information; Availability," pp. 22; posted 8 April 2003.
  15. Initial Formal Comments To Docket 03D-0061 Draft Guidance, Comparability Protocols Chemistry, Manufacturing, and Controls Information, pp. 14; posted 15 May 2003.
  16. Updated Formal Comment To Docket 02D-0526 Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information; Availability," pp. 22; submitted 9 May 2003.
  17. Updated Formal Comments To Docket 03D-0061 Draft Guidance, Comparability Protocols Chemistry, Manufacturing, and Controls Information, pp. 14, submitted 9 May 2003.
  18. Review of Formal Comments To Docket 02D-0526 Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information; Availability," pp. 279+; submitted 30 September 2003.
  19. Scientific Review of PQRI Dec 2002 'Recommendation' report-a.pdf, pp. 90, submitted 30 September 2003 [to Dr. Ajaz E. Hussain, Deputy Director of Office of Pharmaceutical Science (OPS) in FDA CDER on or about 17 October 2003 assigned Jon E. Clark, Associate Director for Policy Development, OPS, CDER, FDA].
  20. Review of CDER's Office of Pharmaceutical Science's Draft Guidance for Industry on PAT's Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, pp. 42+, submitted 12 October 2003.
  21. Review of Comments to Docket 03D-0061 Draft Guidance, Comparability Protocols Chemistry, Manufacturing, and Controls Information, pp. 171+; submitted 21 October 2003.
  22. Formal Comments to Docket 03D-0380 - Draft Guidance for Industry on PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, pp. 45+, submitted 30 October 2003.
  23. Formal Comments to Docket 03D-0493 - Draft Guidance for Industry on Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment, pp. 69+, submitted 15 November 2003.
  24. Formal Comments to Docket 03D-0380 - REVISED Draft Guidance for Industry on PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, pp. 36+, submitted 6 January 2004.
  25. Formal Comments to Docket 03D-0493 - REVISED Draft Guidance for Industry on Powder Blends and Finished Dosage Units - Powder Blends And Dosage Units - In-Process Blend And Dosage Unit Inspection (Sampling And Evaluation) For Content Uniformity, pp. 48+, submitted 21 January 2004.
  26. Initial Formal Comments to Docket 03D-0571 - Draft Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information; Availability, pp. 42+, submitted 6 February 2004.
  27. Review of Comments Submitted to Docket 03D-0493 - Draft Guidance for Industry on Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment, pp. 244+, Submitted 30 April 2004.
  28. Addendum to Review of Comments Submitted to Docket 03D-0493 - Draft Guidance for industry on Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment, pp. 42+, Submitted 6 May 2004.
  29. Formal Comments to Docket 03D-0493 - Second Revision to Draft Guidance for Industry on Powder Blends and Finished Dosage Units - Powder Blends And Dosage Units - In-Process Blend And Dosage Unit Inspection (Sampling And Evaluation) For Active Uniformity, pp. 64+, Submitted 15 May 2004.
  30. Submission to Docket 03D-0493 - Guidance for Industry on Powder Blends And Dosage Units - Blend And Dosage Unit Inspection (Sampling And Evaluation) For Active Uniformity, A second proposed revision of the Agency's draft Guidance, pp. 66, Submitted 15 May 2004 (Posted 7 June 2004).
  31. Formal Comments to Docket 04N-0181 - Critical Path Initiative; Establishment of Docket, An in-depth review of Agency's Critical Path white paper and formal comments on the true Critical impediments to safer and truly better medical products, pp. 96+, Submitted 18 June 2004.
  32. Citizen Petition, Docket 2004P-0346 - CITIZEN PETITION REQUESTING CERTAIN ACTIONS WITH RESPECT TO VACCINES AND OTHER DRUG PRODUCTS, CONTAINING ADDED MERCURY, IN ORDER TO REDUCE THE HEALTH RISK TO SUSCEPTIBLE FETUSES, NEWBORNS, CHILDREN, ADOLESCENTS AND ADULTS, pp. 61+, Filed 4 August 2004.
  33. Formal 'SIGNIFICANT ADVERSE COMMENTS' to Docket 2004N-0214 - Public Information Regulations, Direct Final Rule pp. 9, Submitted 28 September 2004.
  34. Formal Comments to a 'Citizen Petition' submitted by the National Vaccine Information Center (NVIC) in December of 2001 and Posted To The FDA's Public Docket 02P-0025 - Immediate suspension all vacciness containing Thimerosal *, pp. 19+, Submitted 30 September 2004.
  35. Formal Comments to Docket 2004D-0443 - Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, pp. 30+, Submitted 24 November 2004.
  36. Formal Docket Comments' Review Comment To: Docket 2004D-0443 - Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, pp 192+, Submitted 18 January 2005.
  37. Formal Revised Draft Guidance Comment To: Docket 2004D-0443 - Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. pp. 39+, Submitted 18 January 2005.
  38. Revision Rationale Comments For: The Revised Draft Guidance Comment To: Docket 2004 D-0443 - Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. pp. 18+, Submitted 18 January 2005.
  39. Formal CoMeD Response Letter to FDA's 180-day-response letter to CoMeD's Citizen Petition, Submitted To: Docket 2004P-0349, titled, Action on Products containing added Mercury, by the FDA, pp 19, Submitted 23 February 2005; Posted to Docket on 02 March 2005.
  40. Formal 'SIGNIFICANT ADVERSE COMMENTS' to Docket 2004N-0214 - "Public Information Regulations, Direct Final Rule", pp. 9, Submitted 28 September 2004.
  41. Formal Comments to a 'Citizen Petition' submitted by the National Vaccine Information Center (NVIC) in December of 2001 and Posted To The FDA's Public Docket 02P-0025 - "Immediate suspension all vacciness containing Thimerosal *," pp. 19+, Submitted 30 September 2004.
  42. Formal Comments to Docket 2004D-0443 - "Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations," pp. 30+, Submitted 24 November 2004.
  43. Formal Comments to Docket 2006P-0480 - "Complementary and Alternative Medicine Products & Their Regulation by the FDA", pp. 20, Submitted 29 April 2007.
  44. Formal CoMeD Comments to FDA-2010-N-0099, CoMeD opposition to the FDA's proposal to weaken the safety standards for vaccines and other biologics (25 June 2010, 10 pages)
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STANDARD OPERATING PROCEDURES (SOPS)

  1. SOP: QC-0105.A AIR-SEGEMENTED, CONTINUOUS-FLOW AUTOMATED HYDROXYLAMINE COLORIMETRIC ANALYSIS OF AMPICILLIN TRIHYDRATE CAPSULES.
  2. SOP: DISSO 2.098 CALCULATION OF SCIENTIFICALLY SOUND CHEMICAL RELEASE RESULTS IN DISSOLUTION PROFILE AND CHEMICAL RELEASE TESTING.
  3. SOP: QC-0096.D INSTRUMENTATION FITNESS.
  4. SOP: QC-0087.A RECORDING OF ANALYTICAL DATA.
  5. SOP: QC-0075.C SAME-VIAL REPRODUCIBILITY LIMITS FOR GAS AND LIQUID CHROMATOGRAPHIC INJECTIONS
  6. SOP: QC-0060.E STABILITY TESTING PROGRAM
  7. SOP: QC-0051.D THE CRITICAL EVALUATION OF DATA
  8. SOP: QC-0042.A THE VALIDATION OF ANALYTICAL TEST METHODS
  9. SOP: AD-0021.A THE GENERATION OF STANDARD OPERATION PROCEDURES
  10. SOP: VA-0003.A THE GENERATION OF VALIDATION PROTOCOLS
  11. SOP: QC-0072.A VALIDATION OF QUANTITATIVE GAS & LIQUID CHROMATOGRAPHIC METHODS
  12. SOP: QC-0084.A SPOT CHECKING OF OUTSIDE LABORATORIES, USING "SPIKED" OR "SURROGATE" SAMPLES, FOR TESTING THE ACCURACY OF THEIR REPORTING
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STATUTES & RELATED DOCUMENTS

  1. Rough Draft Of The Proposed Federal Drug Safety Act of 2005, pp. 45, Released for review on 15 December 2004.
  2. Synopsis Of The Federal Drug Safety Act of 2005, pp. 3, Released for use on 3 January 2005.
  3. Revised Proposed Mercury-Free Drugs Act of 2005 (Sixth Draft, pp. 6, Released for distribution on 12 January 2005.
  4. Second Draft Of The Proposed Federal Drug Safety Act of 2005, pp. 45, Released for review on 12 January 2004.
  5. Revised Final Draft of Mercury-Free Drugs Act of 2005, pp. 6, Released for distribution on 15 February 2005.
  6. Revised Synopsis Of The Federal Drug Safety Act of 2005, pp. 3, Released for use on 11 February 2005.
  7. Sixth Draft Of The Proposed Federal Drug Safety Act of 2005, pp. 46, Released for review on 14 February 2005.
  8. "CoMeD Suit To Compel DHHS/FDA Response To CoMeD Citizen Petition 2004P-0349 (1 August 2006, 17 pages)."
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WHITE PAPERS

1996

1997

1998

1999

2000 - None

2001

2002

2003

2004

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