Improving Innovation in Medical Technology: Beyond 2002--Executive Summary
...These initiatives, along with more guidance to sponsors, will enable sponsors to focus studies to yield maximum information during.....In 2002, the Food and Drug Administration cleared for marketing just under 5000 new drugs.....In addition, recent research has shown that the cost of developing a new drug has..
http://www.fda.gov/bbs/topics/news/2003/beyond2002/execsumm.html (score=100)

Food and Drug Administration Progress and Priorities 2004
...The drug product is indicated for the control of pain and inflammation associated with.....Recent studies(1) have estimated nearly double the number of deaths from medical errors.....This is the first resource to give the public comprehensive access to a drug product's approval..
http://www.fda.gov/oc/initiatives/reports/priorities2004.html (score=61)

...Each product, each drug, each concentration may have its own unique profile, and that's why you do a.....We're not talking about therapeutic substitution, where one substitutes or studies a.....You can relate the potency of the steroid in the release of the drug from the product into the skin by..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3804t2.htm (score=59)

Document
...drug experiences are submitted if there is a reasonable possibility that the drug caused the adverse drug.....reports from post-marketing studies, reports in the sci-entific literature, and foreign.....Induced cardiac arrhythmias, many other cases, the biological product same meaning as..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.pdf (score=59)

Document
...as safe and effective and not misbranded active ingredients in OTC drug products document.....The studies included antiperspirant-treated axilla to rate of ..in sweat production.....product effectiveness. revising the guidelines to state: revising the relative humidity..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=22)

FR Doc 03-14140
...Any drug product labeled, represented, or promoted for use as an OTC antiperspirant drug that.....An average of 43 subjects completed the 1-week studies and returned their product to the.....A drug product that, when applied topically to the underarm, will reduce the production of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=22)

Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and...
...In some cases, pediatric studies of a drug or biological product for life-threatening diseases may begin as early as phase.....You can get specific information about the types of pediatric studies that should be conducted for your drug product from the.....Where possible, an estimate of patient exposure to the drug product, with special reference to..
http://www.fda.gov/cder/guidance/3578dft.htm (score=21)

FDA Approval of New Cancer Treatment Uses for Marketed Drug an
...If the safety/toxicity profile of a product has been well established in prior studies, the safety data needed to support additional.....1 This guidance has been prepared by the Division of Oncology Drug Products in the Center.....Product labeling is intended to provide full prescribing information for a product and..
http://www.fda.gov/cder/guidance/1484fnl.pdf (score=21)

Document
...methods that optimize safety, safety and effectiveness of the product, studies contemplated under.....to convene a panel of pediatric experts, existing drug advisory committees, FDA agrees.....Vital and Health Statistics, Procedures, Priority Review Policy, product, including a..
http://www.fda.gov/ohrms/dockets/98fr/120298c.pdf (score=21)

/a/content.30891
...to conduct and analyze renal studies, hepatic studies, 13.. population PK, and in all those guidances, we.....rate and extent of drug absorption, its pharmacokinetics, 16.. pharmacodynamics, and the.....product for the first time without doing in vivo testing, 25.. and the answer to that is..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=21)

...In some cases, pediatric studies of a drug or biological product for life-threatening diseases may begin as early as phase.....You can get specific information about the types of pediatric studies that should be conducted for your drug product from the.....Where possible, an estimate of patient exposure to the drug product, with special reference to..
http://www.fda.gov/cder/guidance/3578dft.doc (score=21)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....conduct and/or complete prescribed studies on production batches of a drug after approval.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=21)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...This evaluation provides the link between the new combination drug product and the drug.....However, drug-drug interaction studies should be conducted between the therapeutic components of the FDC or co.....15 Sponsors should evaluate the stability of the drug product in the actual dispensing package..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=21)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....E provide information on the design of initial clinical trials for nonmarketed botanical drug products and for expanded.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=20)

MedWatch - June 2002 Safety-Related Drug Labeling Changes
...No clinically significant drug-drug interactions between itraconazole, theophylline, warfarin.....These results and the data from in vitro studies suggests that moxifloxacin is unlikely to.....A statement to patients and health care providers is included on the product’s bottle..
http://www.fda.gov/medwatch/SAFETY/2002/jun02.htm (score=20)

FDA Pharmaceutical Product International Activities
...The Division of Drug Information acts as the Center's main drug information contact and.....What needs to be done before I import a bulk drug product to the United States? Where can I get.....drug studies, and ensures that product quality and safety are maintained after marketing. CDER..
http://www.fda.gov/oia/drugnew.htm (score=139)

DEPARTMENT OF HEALTH & HUMAN SERVICES
...In addition to the serious deficiencies associated with the investigational new drug studies.....enrollment and administration of the investigational activated cell product to human.....You failed to withhold administration of an investigational new drug until an IND is in..
http://www.fda.gov/foi/warning_letters/g2035d.htm (score=99)

pediatric rule1994
...mechanism by which many psychiatric drugs work is not known, so that, for these drug.....drug product's effectiveness in each group. It may, on the other hand, be important to have.....on adequate and well-controlled studies in the pediatric population. The pediatric age..
http://www.fda.gov/cder/pediatric/pediatric_rule1994.htm (score=60)

Human Subject Protection; Foreign Clinical Studies Not Conducted Under an...
...safe use of the proposed drug product, studies provided they are well-designed, provides assurance that.....decisionmaking on product applications of nonIND foreign clinical trials of drug support.....1975 version (46 FR 8942, January 27, of foreign clinical studies not conducted comments..
http://www.fda.gov/cber/rules/forclinstud.pdf (score=21)

Compliance Policy Guides: Radiofrequency Identification Feasibility Studies...
...The goal of this CPG is to facilitate the performance of RFID studies and allow industry.....The tags will not contain or transmit advertisements or information about product.....Drug Application.2 The study need not have a pre-determined time limit or endpoint, except..
http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html (score=21)

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