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DIOGENES is a comprehensive source of information relating to
the regulation of drugs and medical devices by the US Food and
Drug Administration (FDA). The database contains unpublished
FDA documents acquired under the Freedom of Information Act
such as Drug and Device Approval information, The Enforcement
Report, and Medical Device Reports.
Use DIOGENES to answer such questions as:
- which pharmaceutical firms have FDA approval to produce
generic equivalents of Valium?
- what are the Federally-mandated performance standards for
sunbeds?
- what tests were conducted to determine the safety and efficacy
of Tagamet?
- what animal studies must be conducted before a contraceptive
can be clinically tested?
- under what emergency circumstances can unapproved medical
devices be used?
Sources
FDA sources include Premarket Notifications (510(k)s), PMAs
(Premarket Approvals), Medical Device Reports, New Drug
Application Lists, and records of The Enforcement Report.
Premarket Notifications (510(k)s) - updated monthly:
DIOGENES lists every device ever declared substantially
equivalent, and therefore allowed onto the market under the
Premarket Notification provisions of the Medical Device
Amendments of 1976. Information available includes device name
and classification, regulating advisory committee, sponsoring
company, date of FDA decision, and 510(k) number.
Premarket Approvals (PMAs) - monthly:
Supplementing the listing of 510(k)s is the listing of all
medical devices approved under the Premarket Approval provisions
of the Medical Device Amendments of 1976. Individual entries
include device name and manufacturer, date of approval, and
regulating advisory committee.
Medical Device Reports (MDRs) - quarterly:
Covering back to the beginning of the Medical Device Reporting
plan in 1985, this data set includes a record describing each
adverse device experience submitted to the FDA.
New Drug List (NDL) - monthly:
The DIOGENES database includes a listing of every drug ever
allowed onto the U.S. market since approval requirements began
in 1938. Individual records include drug generic and trade
names, manufacturer, dosage strength and form, New Drug
Approval (NDA) or Abbrviated New Drug Approval (ANDA) number,
and date of approval. For affected drugs, date of market
withdrawal, date of withdrawal of FDA permission to market,
Waxman-Hatch patent number, patent expiry, and patent
exclusivity dates are also included.
The Enforcement Report - weekly:
Covering back to 1984, each record of The Enforcement Report
describes an instance of FDA-recorded field corrections and
product recalls, indexed by company, product, recall number,
extent of recall and recall narrative. The Enforcement Report
describes pharmaceuticals, medical devices, biologics, foods,
radiological products, veterinary medical products, and
cosmetics.
Sample of a Premarket Notification (510(k) document:
AN - Accession number & update:
909376 20050215.
OC - Occurrences:
PARAGRAPH
SO (1).
TI - Title:
MODIFICATION TO VERTE-STACK SPINAL SYSTEM; SUMMARY AVAILABLE
FROM FOI SERVICES OR FDA.
AU - Author(s):
Advisory committee : ORTHOPEDIC DEVICE PANEL (DVORTHO).
SO - Source:
FDA 510(K) LIST (510k); LIST EDITION: January 2005.
DT - Publication date:
20041229.
CO - Company name:
MEDTRONIC.
NU - FDA numbers:
Drug/Device No. : K043561.
DE - Descriptors:
(MQP) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE CLASS NOT
PROVIDED BY FDA CFR
CITATION NOT PROVIDED BY FDA.
ST - Status:
Submission date: 20041227
Submission type: SPECIAL
Substantial Equivalence: (SE) SUBSTANTIALLY EQUIVALENT
Device subfile: 510K.
PT - Publication type:
DEVICE (DEV).
LE - Length:
1,520 Characters, approximately 1 PC screen.
LG - Language:
English.
Sample of a Premarket Approval (PMA) document:
AN - Accession number & update:
3015888 20050215.
OC - Occurrences:
PARAGRAPH
SO (1).
TI - Title:
SUPPLEMENTAL PMA: SALINED-FILLED BREAST IMPLANTS (S016).
AU - Author(s):
Advisory committee : GENERAL AND PLASTIC SURGERY DEVICE
PANEL (DVGENPLAS).
SO - Source:
FDA PMA LIST (PMA); LIST EDITION: January 2005.
DT - Publication date:
20041217.
CO - Company name:
INAMED.
NU - FDA numbers:
Drug/Device No. : P990074.
DE - Descriptors:
(FWM) PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
CLASS: 3 21CFR 878.353.
ST - Status:
Submission type: NOT EXPEDITED
Device subfile: PMA
Supplement type: NORMAL 180 DAY TRACK NO USER FEE
Supplement reason: LABELING CHANGE - OTHER.
PT - Publication type:
DEVICE (DEV).
LE - Length:
1,440 Characters, approximately 1 PC screen.
LG - Language:
English.
Sample of a Medical Device Report (MDR) document:
AN - Accession number & update:
2259048 20031107.
OC - Occurrences:
PARAGRAPH
SO (1).
TI - Title:
MDR REPORT: INION LTD. INION CPS BIOABSORBABLE SYSTEM BONE
FIXATION FASTENER
Model# SCR-1216 Catalog# SCR-1216 - MALFUNCTION.
AU - Author(s):
Advisory committee : ORTHOPEDIC DEVICE PANEL (DVORTHO).
SO - Source:
FDA-MDR-LIST (MDR); LIST EDITION: NOVEMBER 2003.
DT - Publication date:
20021114.
CO - Company name:
INION LTD.
AD - Address:
LAAKARINKATU 2.
DE - Descriptors:
(HWC) SCREW, FIXATION, BONE CLASS: 2 21 CFR: 888-3040 888.3040.
ST - Status:
Device subfile: MDR.
DT - Publication type:
DEVICE (DEV).
TX - Text:
POSSIBLY PATIENT HAD MUSCLE SPASM, AND THE SPLINT THEREFORE,
WOULD NOT FIT PROPERLY. THE PATIENT THEN WOULD HAVE LIE DOWN
ON THE SPLINT TO FORCE THE TEETH TO FIT PROPERLY. WHEN THIS
MOTION OCCURRED THE SCREWS FRACTURED BECAUSE OF THE EXTRA
FORCE. THE ONLY THING DIFFERENT IN THIS CASE WAS THAT HE
NORMALLY (DOCTOR) USES FOUR SCREWS INSTEAD OF THREE. SINCE
THIS CASE DOCTOR HAS USED THREE SCREWS TWICE WITHOUT ANY
PROBLEMS.
LE - Length:
1,840 Characters, approximately 1 PC screen.
LG - Language:
English.
Sample of a New Drug List (NDL) document:
AN - Accession number & update:
4026501 20050203.
OC - Occurrences:
PARAGRAPH
AN (1).
TI - Title:
ORIGINAL OR SUPPLEMENTAL NDA: CADUET; AMLODIPINE BESYLATE EQ
2.5MG BASE; ATORVASTATIN CALCIUM EQ 20MG BASE.
SO - Source:
FDA-APPROVED DRUGS SINCE 1938 (NDL) - LIST EDITION: JANUARY
2005.
DT - Publication date:
20040729.
CO - Company name:
PFIZER.
PN - Product name:
Trade name : CADUET
Generic name : AMLODIPINE BESYLATE EQ 2.5MG BASE; ATORVASTATIN
CALCIUM EQ 20MG BASE.
NU - FDA numbers:
Drug/Device No. : 21540.
DE - Descriptors:
Dosage form: TABLET
Route of administration: ORAL.
ST - Status:
Discontinued date: Y.
PA - Patent information:
Patent expiration 20150511.
Patent number 5686104*PED.
PT - Publication type:
DRUG (DRG).
LE - Length:
1,440 Characters, approximately 1 PC screen.
LG - Language:
English.
Sample of a record of The Enforcement Report
AN - Accession number & update:
E0146083 20050211.
OC - Occurrences:
PARAGRAPH
AN (1).
TI - Title:
NCS Healthcare of Kentucky CLASS II RECALL 11/30/04 &
12/01/04:
Metoclopramide Tablets, 5mg; Folic Acid tablets, 1mg.
SO - Source:
FDA ENFORCEMENT REPORT 02/02/2005.
CO - Company:
NCS Healthcare of Kentucky, Inc., Glasgow, KY.
PN - Product name:
Generic name: Metoclopramide tablets, 5mg & folic acid
tablets, 1mg.
NU - FDA numbers:
FDA No. : #D-0107-5; #D-0108-5.
PT - Publication type:
DRUG (DRG).
TX - Text:
PRODUCT
a) Metoclopramide Tablets, USP, 5 mg tablets, Rx only,
packaged in 30 and 31 count grid cards. NDC 0615-3546-39
and NDC 0615-3546-31. Recall # D-107-5; b) Folic Acid
Tablets, USP, 1 mg, Rx only, packaged in 30 and 31 count
grid cards. NDC 0615-0664-39 and NDC 0615-0664-31. Recall
# D-108-5.
CODE
a) Lot 3546-4009, exp. Date 10/31/05 and
Lot 3546-4009, exp. Date 10/31/05;
b) Lot 0664-4010, exp. Date 10/31/05 and
Lot 0664-4010, exp. Date 10/31/05.
RECALLING FIRM/MANUFACTURER
NCS Healthcare of Kentucky, Inc., Glasgow, KY, by facsimile
on November 30, 2004 and by letter on December 1, 2004. Firm
initiated recall is ongoing.
REASON
Mislabeling, the outside grid card package is labeled as
Metoclopramide, 5 mg, however, individual blister packages
contained within the grid cards are labeled as, and contain,
Folic Acid, 1 mg.
VOLUME OF PRODUCT IN COMMERCE
38,354 packages.
DISTRIBUTION
Nationwide.
LE - Length:
2,725 Characters, approximately 2 PC screens.
LG - Language:
English.
Label/description Examples
AN Accession number 1_: 4031620.AN.
& update 2_: 20050203.AN.
- see also LIMIT options -
OC Occurrences - display only -
TI Title 3_: PREGNANCY ADJ TEST.TI.
AU* Author(s) 4_: SMITH-P$.AU.
or for a list using a stem 5_: ..ROOT SMITH-P.AU.
Advisory Committee abbreviation 6_: DVCLINCHEM.AU.
(see Appendix I in BASE for Advisory Com. abbreviations)
SO Source 7_: FDA ADJ 510.SO.
PC* Product Category 8_: BIOLOGIC.PC.
DT Date of publication 9_: 20050126.DT.
or for a date: 10_: DATE=20050126
or for a month: 11_: MONTH=200501
or for a year: 12_: YEAR=2005
- see also LIMIT options -
NT* Notes 13_: FOI ADJ SERVICES.NT.
CO* Company name 14_: HALSEY ADJ DRUG.CO.
or for a list 15_: ..ROOT HALSEY.CO.
AD* Address 16_: ABBOTT ADJ PARK.AD.
PN* Product name (TN and SY) 17_: CADUET.PN.
TN* Trade name 18_: CADUET.TN.
SY* Generic names 19_: AMLODIPINE ADJ
BESYLATE.SY.
NU* FDA numbers 20_: D-0107-5.NU.
Drug/Device numbers 21_: K990373.NU.
DE* Descriptors 22_: PREGNANCY.DE.
FDA Device code 23_: LCX.DE.
Dosage form 24_: DOSAGE WITH TABLET.DE.
Route of administration 25_: ROUTE WITH ORAL.DE.
Keywords 26_: BETA ADJ '2' ADJ
MICROGLOBULIN.DE.
ST* Status
Discontinued date 27_: DISCONTINUED WITH
19910327.ST.
Marketing Exclusivity date 28_: MARKETING WITH
20010310.ST.
Withdrawal code 29_: MUTUAL ADJ AGREEMENT.ST.
Withdrawal date 30_: WITHDRAWAL WITH .
19970725.ST.
Submission date 31_: SUBMISSION WITH .
19991006.ST.
Submission type 32_: EXPEDITED.ST.
Substantial Equivalence text 33_: SUBSTANTIALLY ADJ
EQUIVALENT.ST.
Device subfile 34_: PMA.ST.
Supplement type 35_: SPECIAL.ST.
Supplement reason 36_: CHANGE WITH DESIGN.ST.
PA* Patent information
Patent number 37_: 4572909.PA.
Patent expiration, e.g. 38_: 201501$2.PA.
Patent use code 39_: ARTHRITIS.PA.
Patent use code 40_: U ADJ '247'.PA.
PT Publication type 41_: PT=DEV
or for a list 42_: ..ROOT PT=
TX* Text 43_: ANTIBODY WITH ASSAY.TX.
LE Length of document - display only -
LG Language - display only -
* These paragraphs are not available in all documents.
Initial search to select records 1_: IMMUNOFLUORESCENT.TI.
DATE Publication date 2_: ..L 1 DATE>20050228
MONTH Publication month 3_: ..L 1 MONTH>200502
YEAR Publication year 4_: ..L 1 YEAR WL 2003,2004
AN Accession number 5_: ..LIMIT 1 AN WL
700000,799999
UDATE Update date 6_: ..L 1 UDATE>20040726
UMONTH Update month 7_: ..L 1 UMONTH>200504.
By paragraph, for example show title and source for the first
three items of search number 1:
1_: ..PRINT 1 TI, SO 1-3
By using a named format:
SHORT AN TI AU SO DT LE YR
MEDIUM AN TI AU SO PC DT CO PN TN SY DE TX LE YR
LONG AN TI AU SO PC DT CO AD PN TN SY DE ST PA TX LE YR
ALL AN OC TI AU SO PC DT NT CO AD PN TN SY NU DE ID ST
PA PT TX LE LG YR
FREE AN OC TI PC DT NT AD TN SY PA PT LE LG YR
Search Options:
..SET MEDWORD ON can be selected in DIOG.
Search aids:
DIOGENES - FDA Regulatory Information: Pharmaceuticals & Medical
Devices. Users Guide. February 1994.
Some documents referenced in Diogenes are available from the
producer in hard copy.
DIOGENES:
All bibliographic information and record identification in
DIOGENES is fully protected by copyright. Reproduction or
photocopying even for internal use without the publisher's
permission is prohibited. While every effort has been made to
ensure that the information in the database is correct, DIOGENES
cannot accept any responsibility for errors or omissions.
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