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Foi and iig Foi and iig Presentation Transcript

  • FREEDOM OF INFORMATIONINACTIVE INGREDIENT GUIDE
  • FREEDOM OF INFORMATION (FOI)• Contains categories of frequently requested FDA documents.• Check for availability on FDA web site.• Can also check specific FOI sites which have been established by the following agency offices :
  •  Center for drug evaluation and research (CDER)Center for biologics evaluation and research (CBER)Center for devices and radiological health (CDRH)Center for veterinary medicine (CVM)Dockets management branch (DBM)Office of regulatory affairs
  •  Advisory committee transcripts Application integrity policy test Clinical investigators inspection list Information on commissioning Compliance policy guides Compliance program guidance manual Directory of public affair specialist Directory of state officials Enforcement reports Guides to inspection Import alerts Import refusal reports
  •  Inspectors technical guide Lab information bulletins Laboratory procedures manual Medical devices reports NADA FOI summaries Notice of opportunity for hearing Products approval Regulatory procedures manual Warning letters
  • A handbook for requesting informationand records from FDA The guidance given in this handbook is intended to facilitate requests for both public information and records.  This handbook has been updated in response to the Electronic Freedom of Information Act Amendments of 1996.
  • Obtaining Public InformationCertain documents that are prepared forpublic distribution--such as press releases,consumer publications, speeches, andcongressional testimony--are available fromFDA without having to file a Freedom ofInformation Act (FOIA) request. Many ofthese documents are available on FDAsInternet site (http://www.fda.gov/default.htm).
  • Obtaining Information Through FOIA→ FOIA allows anyone to request copies of records→ FOIA pertains to existing records only→ Does not require agencies to create new records to comply with a request→ FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable period of time.
  • Under FOIA, certain records may be withheld inwhole or in part from the requestor if they fallwithin one of nine FOIA exemptions.Exemption 2: Protects certain recordsrelated solely to FDAs internal rules andpractices.Exemption 3: Protects information that isprohibited from disclosure by other laws.Exemption 4: Protects trade secrets andconfidential commercial or financialinformation.
  • Exemption 5: Protects certain interagencyand intra-agency communications.Exemption 6: Protects information aboutindividuals in personnel, medical, and similarfiles when disclosure would constitute aclearly unwarranted invasion of privacy.Exemption 7: Protects records or informationcompiled for law enforcement purposes whendisclosure (A) could reasonably be expectedto interfere with enforcement proceedings;
  • (B) would deprive a person of a right to a fair trialor an impartial adjudication; (C) could reasonably be expected to constitute anunwarranted invasion of personal privacy;(D) could reasonably be expected to disclose theidentity of a confidential source;(E) would disclose techniques and procedures forlaw enforcement investigations or prosecutions, orwould disclose guidelines for law enforcementinvestigations or prosecutions, if such disclosurecould reasonably be expected to riskcircumvention of the law.
  • How To Make an FOIA Requesta. Requestors name, address, and telephone number.b. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less.
  • c. Separate requests should besubmitted for each firm or productinvolved.d. A statement concerningwillingness to pay fees, includingany limitations.
  • Electronic Reading RoomsThe 1996 amendments to the Freedomof Information Act (FOIA) mandatepublicly accessible "electronic readingrooms" with agency FOIA responsematerials and other informationroutinely available to the public, withelectronic search and indexing features.
  • Freedom of Information (FOI) Reference Sheet This table descripts the types of information that are releasable through the Freedom of Information (FOI) process from FDA ELEMENTS PREMARKET APPROVAL INVESTIGATIONAL PREMARKET (PMA) Documents 21 CFR DEVICE EVALUATION NOTIFICATION (PMN/510k) 814.9 (IDE) Documents 21 CFR 21 CFR 807.95 812.38Appeals Only through FOI Staff, HFZ-82 Only through FOI Staff, HFZ- Only through FOI Staff, HFZ-82 82Adverse Released by ODE, to the patient Not releasable, except to Released by ODE, to the patientEffects / only, after receipt of written provide a patient with their only, after receipt of writtenReaction request. If requested by an own report request. If requested by anReports in attorney or family member; need attorney or family member; needPMAs, IDEs & notarized authorization from the notarized authorization from the510(K)s patient. patient.Approval Letter available through Dockets Not Releasable Only releasable only by FOI Staff,Letters Management with the SS&E HFZ-82 package or on the Internet
  • Approvable Generally not releasable. See N/A N/ALetters FOI Staff.Bench/Clinical Not Releasable Not Releasable Not ReleasableDataConsent Forms Releasable only to those Releasable only to those Releasable only to those participants in the PMA study if participants in the IDE study if participants in the 510k study & if reviewer is able to identify the reviewer is able to identify the reviewer is able to identify the individual in the document. If individual in the document. If individual in the document. If requested by an attorney or requested by an attorney or requested by an attorney or family family member, it must be family member, it must be member, it must be accompanied accompanied by a notarized accompanied by a notarized by a notarized authorization from authorization from the patient. authorization from the patient. the patient.Certifications of Only through FOI Staff, HFZ-82 Only through FOI Staff, HFZ- Only through FOI Staff, HFZ-82Documents 82Denials Only through HFZ-82 and Only through HFZ-82 and Only through HFZ-82 and coordinated through General coordinated through General coordinated through General Counsel Counsel CounselLabeling Contained in summary of safety N/A or Not Releasable Releasable by FOI HFZ-82 after and effectiveness (SS&E) and PDN released by Dockets Management; some may be found on the Internet
  • Manufacturers Not Releasable Not Releasable Not ReleasableStandardOperatingProcedures(SOP), In-houseQualityAssuranceProceduresMinor Deletions Only through HFZ-82 N/A Only through FOI Staff, HFZ-82Not N/A N/A May be releasable, see FOI StaffSubstantiallyEquivalentDocumentPatient Records Releasable only to those Not releasable except to Not releasable except to provide a participants in the PMA study if provide a patient with their patient with their own report reviewer is able to identify the own report individual in the document. If requested by an attorney or family member, it must be accompanied by a notarized authorization from the patient.PMA Review for proprietary N/A N/ASupplements information prior to release
  • Recession Releasable only after recession May be releasable, see FOI Releasable only after recession isLetters is effective Staff effectiveReviewers Review for proprietary Not Releasable Review for proprietaryNotes information prior to release information prior to releaseSubstantially N/A N/A Available on the Internet as ofEquivalent 7/97, otherwise only releasableLetter through FOI, HFZ-82Summary of Releasable through ODE or N/A Available on the Internet forSafety and Dockets Management (with a 510(K)s found SE after MarchEffectiveness Docket Number); approvals after 1996. Voluntarily submitted by(SSE) 9/96 on Internet manufacturer and intended for public release. Note that the SS&E were not required prior to 4-18-91.Withdrawn Not Releasable, see FOI Staff N/A Not Releasable - see FOI StaffSubmissionWithdrawn Not Releasable - see FOI Staff Not Releasable - see FOI Staff Not Releasable - see FOI StaffLetter
  • Inactive Ingredient Guide• IIG is a part of FOI Special Topics, which comes under Drug Information division of CDER.• IIG was prepare on January 1996• PDF version available on FDA from March 2000 – scanned document• Divided in 8 Parts – alphabetically.• Total Pages 155
  • Inactive Ingredient Guide• IIG consist of all the inactive ingredient present in approved drug product or conditionally approved drug products currently marketed for human use.• IIG is compile by DDIR – Division of Drug Information Resources.
  • Purpose• Once Inactive Ingredient appears in currently approved drug products for particular route of administration, the Inactive Ingredient would not usually be considered NEW and may require less extensive review.
  • Inactive Ingredient• 21 CFR 210.3 (b) 8 defines Inactive Ingredient as any component other than Active Ingredient.• Only those which are present in Final dosage form.• Not include any processing material used, which removed afterwards and not present in Final dosage form.
  • Inactive Ingredient• Inactive Ingredient, which is Physically or Chemically combined with Active ingredient to facilitate DRUG TRANSPORT are considered as Inactive Ingredient.• Reactant in Radiopharmaceuticals.
  • Contaminants• IIG does not represents contaminant found in approved drug products.
  • Synonyms• Since many Ingredient have Synonyms, if one can not find any particular Ingredient, he may contact Drug Information Officer, who can assist with the help of Dictionary maintained by DDIR.
  • Proprietary Name• DDIR does not always include Proprietary names of Ingredient in IIG.• In such situations, one has to search data for such ingredient under individual component entries.
  • Toxics• If any ingredient of IIG is found to be Carcinogenic or Teratogenics or Embryotoxic, please NOTIFY to DDIR• DDIR draws attention of medical officers and pharmacological reviewer towards that specific Inactive Ingredient
  • Color Additives• Specially listed at last in Appendix• Certification Branch of Division of Color Technology had classified colors. – Permanently listed color additives – Provisionally listed color additives – Delisted color additives• Consult 21 CFR 74 and 82 for detail information on color additives
  • IIG DescriptionNAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATE
  • IIG DescriptionNAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATEAlphabetically listedStarting from ACACIA to ZINC SULFATEThen few excipients as per Numerical startinge.g. 1,1,1 - TRICHLOROETHANE
  • IIG DescriptionNAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATERoute; Dosage form; specifici.e.Oral; Tablet; Delayed action, Enteric CoatedAlphabetical order : Buccal, I.M., I.V., Ophthalmic, Oral, Topical
  • IIG Description NAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATEChemical Abstract Service No. - 9 digitHelpful in Computer-assisted search with theNational Library of Medicine’s Online Databases
  • IIG DescriptionNAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATETotal No. of NDA filed,in which Inactive Ingredient currently appears
  • IIG DescriptionNAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATEDate of obtaining Last NDA approval,Helps to find Latest NDA
  • IIG DescriptionNAME ROUTE / CAS NDA LAST NDA POTENCY DOSAGE NO. COUNT APPROVAL RANGE FORM DATEMinimum to Maximum Value of Excipient usedi.e. 0.5 mg – 5 mgIn many excipient Potency Range is given inPercentage of final producti.e. 0.5 % - 5 %
  • Structures• Chemical Structures of Inactive Ingredient are not mentioned in IIG.• If any one requires for review, it can be obtained from DDIR Chemist.
  •  www.fda.gov