Center for Drug Evaluation and Research (U.S.)
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Center for Drug Evaluation and Research (U.S.)
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The organization Center for Drug Evaluation and Research (U.S.) represents an institution, an association, or corporate body that is associated with resources found in Biddle Law Library- University of Pennsylvania Law School.
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- Center for Drug Evaluation and Research (U.S.)
248 Items by the Organization Center for Drug Evaluation and Research (U.S.)
8 Items that are about the Organization Center for Drug Evaluation and Research (U.S.)
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- E 16 genomic biomarkers related to drug response : context, structure, and format of qualification submissions
- E2f development safety update report
- Está enfermo uno de sus hijos? : No adivine. Lea las indicaciones
- FDA Medical Library serials holding list
- Frecuentes preguntas acerca de las drogas genéricas
- Good laboratory practice regulations, questions and answers
- Guidance : PET drug products, current good manufacturing practice (CGMP)
- Guidance : drug safety information, FDA's communication to the public
- Guidance : expiration dating of unit-dose repackaged drugs, compliance policy guide
- Guidance : topical dermatologic corticosteroids, in vivo bioequivalence
- Guidance for hospitals, nursing homes and other health care facilities
- Guidance for indusry : bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action
- Guidance for indusry : integrated summary of effectiveness
- Guidance for industry - dosage delivery devices for OTC liquid drug products
- Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms
- Guidance for industry : 180-day exclusivity when multiple ANDAs are submitted on the same day
- Guidance for industry : 180-day generic drug exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation
- Guidance for industry : ANDAs, impurities in drug products
- Guidance for industry : CGMP for phase 1 investigational drugs
- Guidance for industry : E 10 choice of control group and related issues in clinical trials
- Guidance for industry : E 10 choice of control group and related issues in clinical trials
- Guidance for industry : E 11 clinical investigation of medicinal products in the pediatric population
- Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
- Guidance for industry : E2B(M), data elements for transmission of individual case study reports, questions and answers
- Guidance for industry : E2BM data elements for transmission of individual case safety reports
- Guidance for industry : E2E pharmacovigilance planning
- Guidance for industry : E6 good clinical practice, consolidated guidance
- Guidance for industry : E9 statistical principles for clinical trials
- Guidance for industry : IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer
- Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information
- Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information
- Guidance for industry : M2 eCTD : electronic common technical document specification
- Guidance for industry : M2, eCTD specification, questions & answers and change requests
- Guidance for industry : M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals
- Guidance for industry : M4, organization of the CTD
- Guidance for industry : M4, the CTD, efficacy questions and answers
- Guidance for industry : M4, the CTD, general questions and answers
- Guidance for industry : M4E, the CTD, efficacy
- Guidance for industry : M4Q, the CTD, quality
- Guidance for industry : M4S, the CTD, safety
- Guidance for industry : M4S, the CTD, safety appendices
- Guidance for industry : NDA's : impurities in drug substances
- Guidance for industry : PAC-ATLS : postapproval changes, analytical testing laboratory sites
- Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance
- Guidance for industry : PET drug applications : content and format for NDAs and ANDAs, fludeoxyglucose F 18 injection, ammonia N 13 injection, sodium fluoride F 18 injection
- Guidance for industry : Prescription Drug Marketing Act (PDMA) requirements, questions and answers
- Guidance for industry : Prescription Drug Marketing Act, donation of prescription drug samples to free clinics
- Guidance for industry : Q1A(R2) stability testing of new drug substances and products
- Guidance for industry : Q1B photostability testing of new drug substances and products
- Guidance for industry : Q1C stability testing for new dosage forms
- Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products
- Guidance for industry : Q1E evaluation of stability data
- Guidance for industry : Q2B validation of analytical procedures, methodology
- Guidance for industry : Q3A impurities in new drug substances
- Guidance for industry : Q3A impurities in new drug substances
- Guidance for industry : Q3B(R2) impurities in new drug products
- Guidance for industry : Q3C impurities, residual solvents
- Guidance for industry : Q3C tables and list
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for Extractable Volume of Parenteral Preparations General Chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter
- Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
- Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products
- Guidance for industry : Q7A good manufacturing practice guidance for active pharmaceutical ingredients
- Guidance for industry : Q8(R2) pharmaceutical development
- Guidance for industry : Q9 quality risk management
- Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals
- Guidance for industry : S1C(R2) dose selection for carcinogenicity studies
- Guidance for industry : S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals
- Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals
- Guidance for industry : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals
- Guidance for industry : S8 immunotoxicity studies for human pharmaceuticals
- Guidance for industry : SPL standard for content of labeling technical Qs & As
- Guidance for industry : SUPAC-IR/MR : immediate release and modified release solid oral dosage forms : manufacturing equipment addendum
- Guidance for industry : SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation
- Guidance for industry : SUPAC-SS : nonsterile semisolid dosage forms : manufacturing equipment addendum
- Guidance for industry : accelerated approval products, submission of promotional materials
- Guidance for industry : acceptance of foreign clinical studies
- Guidance for industry : acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease : developing antimicrobial drugs for treatment
- Guidance for industry : acute bacterial meningitis, developing antimicrobial drugs for treatment
- Guidance for industry : acute bacterial otitis media, developing drugs for treatment
- Guidance for industry : acute bacterial sinusitis, developing drugs for treatment
- Guidance for industry : acute or chronic bacterial prostatitis, developing antimicrobial drugs for treatment
- Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs
- Guidance for industry : adverse reactions section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : advisory committees : implementing Section 120 of the Food and Drug Administration Modernization Act of 1997
- Guidance for industry : aerosol steroid product safety information in prescription drug advertising and promotional labeling
- Guidance for industry : analytical procedures and methods validation, chemistry, manufacturing, and controls documentation
- Guidance for industry : animal models : essential elements to address efficacy under the animal rule
- Guidance for industry : antibacterial drug products, use of noninferiority studies to support approval
- Guidance for industry : antiviral product development, conducting and submitting virology studies to the agency
- Guidance for industry : assay development for immunogenicity testing of therapeutic proteins
- Guidance for industry : available therapy
- Guidance for industry : bioanalytical method validation
- Guidance for industry : botanical drug products
- Guidance for industry : brief summary : disclosing risk information in consumer-directed print advertisements
- Guidance for industry : carcinogenicity study protocol submissions
- Guidance for industry : changes to an approved NDA or ANDA
- Guidance for industry : changes to an approved NDA or ANDA, questions and answers
- Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes
- Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products
- Guidance for industry : classifying resubmissions in response to action letters
- Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling
- Guidance for industry : clinical pharmacology section of labeling for human prescription drug and biological products : content and format
- Guidance for industry : clinical studies section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : clozapine tables, in vivo bioequivalence and in vitro dissolution testing
- Guidance for industry : collection of race and ethnicity data in clinical trials
- Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information
- Guidance for industry : computerized systems used in clinical trials
- Guidance for industry : consumer-directed broadcast advertisements
- Guidance for industry : consumer-directed broadcast advertisements, questions and answers
- Guidance for industry : container closure systems for packaging human drugs and biologics
- Guidance for industry : container closure systems for packaging human drugs and biologics, questions and answers
- Guidance for industry : content and format for geriatric labeling
- Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
- Guidance for industry : contents of a complete submission for the evaluation of proprietary names
- Guidance for industry : cooperative manufacturing arrangements for licensed biologics
- Guidance for industry : court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : development and use of risk minimization action plans
- Guidance for industry : dissolution testing of immediate release solid oral dosage forms
- Guidance for industry : dosage and administration section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : dosage delivery devices for OTC liquid drug products
- Guidance for industry : drug master files for bulk antibiotic drug substances
- Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
- Guidance for industry : electronic signatures, scope and application, Part 11, electronic records
- Guidance for industry : environmental assessment of human drug and biologics applications
- Guidance for industry : estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers
- Guidance for industry : expiration dating and stability testing of solid oral dosage form drugs containing iron
- Guidance for industry : extended release oral dosage forms, development, evaluation, and application of in vitro/in vivo correlations
- Guidance for industry : fast track drug development programs, designation, development and application review
- Guidance for industry : financial disclosure by clinical investigators
- Guidance for industry : food-effect bioavailability and fed bioequivalence studies
- Guidance for industry : formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP
- Guidance for industry : formal dispute resolution, appeals above the division level
- Guidance for industry : formal meetings between the FDA and sponsors or applicants
- Guidance for industry : format and content for the CMC section of an annual report
- Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications
- Guidance for industry : genotoxic and carcinogenic impurities in drug substances and products, recommended approaches
- Guidance for industry : good pharmacovigilance practices and pharmacoepidemiologic assessment
- Guidance for industry : handling and retention of BA and BE testing samples
- Guidance for industry : hypertension indication, drug labeling for cardiovascular outcome claims
- Guidance for industry : immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation
- Guidance for industry : immunotoxicology evaluation of investigational new drugs
- Guidance for industry : implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997, elimination of certain labeling requirements
- Guidance for industry : incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting
- Guidance for industry : independent consultants for biotechnology clinical trial protocols
- Guidance for industry : indexing structured product labeling
- Guidance for industry : information program on clinical trials for serious or life-threatening diseases and conditions
- Guidance for industry : interpreting sameness of monoclonal antibody products under the orphan drug regulations
- Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production
- Guidance for industry : labeling for combined oral contraceptives
- Guidance for industry : labeling for human prescription drug and biological products, implementing the new content and format requirements
- Guidance for industry : labeling guidance for OTC topical drug products for the treatment of vaginal yeast infections (vulvovaginal candidiasis)
- Guidance for industry : liposome drug products, chemistry, manufacturing, and controls; human pharmacokinetics and bioavailablity; and labeling documentation
- Guidance for industry : manufacturing, processing, or holding active pharmaceutical ingredients
- Guidance for industry : metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products; chemistry, manufacturing, and controls documentation
- Guidance for industry : monoclonal antibodies used as reagents in drug manufacturing
- Guidance for industry : nasal spray and inhalation solution, suspension, and spray drug products : chemistry, manufacturing, and controls documentation
- Guidance for industry : national uniformity for nonprescription drugs : ingredient listing for OTC drugs
- Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products
- Guidance for industry : nonclinical safety evaluation of drug or biologic combinations
- Guidance for industry : nonclinical safety evaluation of pediatric drug products
- Guidance for industry : nonclinical studies for the safety evaluation of pharmaceutical excipients
- Guidance for industry : noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms : recommended prescribing information for health care providers and patient labeling
- Guidance for industry : nonsterile semisolid dosage forms : scale-up and postapproval changes : chemistry, manufacturing, and controls : in vitro release testing and in vivo bioequivalence documentation
- Guidance for industry : orally disintegrating tablets
- Guidance for industry : part 11, electronic records : electronic signatures--scope and application
- Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims
- Guidance for industry : pharmaceutical components at risk for melamine contamination
- Guidance for industry : pharmacogenomic data submissions
- Guidance for industry : pharmacogenomic data submissions, companion evidence
- Guidance for industry : photosafety testing
- Guidance for industry : population pharmacokinetics
- Guidance for industry : postmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : powder blends and finished dosage units : stratified in-process dosage unit sampling and assessment
- Guidance for industry : premarketing risk assessment
- Guidance for industry : presenting risk information in prescription drug and medical device promotion
- Guidance for industry : process validation, general principles and practices
- Guidance for industry : product name placement, size, and prominence in advertising and promotional labeling
- Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
- Guidance for industry : providing clinical evidence of effectiveness for human drug and biological products
- Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
- Guidance for industry : providing regulatory submissions in electronic format, content of labeling
- Guidance for industry : providing regulatory submissions in electronic format, general considerations
- Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports
- Guidance for industry : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling
- Guidance for industry : providing regulatory submissions in electronic format, receipt date
- Guidance for industry : public availability of labeling changes in "changes being effected" supplements
- Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : quality systems approach to pharmaceutical CGMP regulations
- Guidance for industry : referencing discontinued labeling for listed drugs in abbreviated new drug applications
- Guidance for industry : reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997
- Guidance for industry : residual solvents in drug products marketed in the United States
- Guidance for industry : safety testing of drug metabolites
- Guidance for industry : single dose acute toxicity testing for pharmaceuticals
- Guidance for industry : standards for securing the drug supply chain : standardized numerical identification for prescription drug packages
- Guidance for industry : statistical approaches to establishing bioequivalence
- Guidance for industry : statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals
- Guidance for industry : sterile drug products produced by aseptic processing, current good manufacturing practice
- Guidance for industry : street drug alternatives
- Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
- Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
- Guidance for industry : submitting and reviewing complete responses to clinical holds
- Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations
- Guidance for industry : testing of glycerin for diethylene glycol
- Guidance for industry : the use of mechanical calibration of dissolution apparatus 1 and 2, current good manufacturing practice (CGMP)
- Guidance for industry : tropical disease priority review vouchers
- Guidance for industry : variations in drug products that may be included in a single ANDA
- Guidance for industry : waiver of in vivo bioavailability studies for immediate-release soild oral dosage forms based on a biopharmaceutics classification system
- Guidance for industry : warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products, content and format
- Guidance for industry M2 : eCTD specification : questions & answers and change requests
- Guidance for industry and review staff : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information
- Guidance for industry and review staff : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route
- Guidance for industry and review staff : recommended approaches to integration of genetic toxicology study results
- Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products
- Guidance for industry, investigators, and reviewers : exploratory IND studies
- Guidance for industry, q & a : content and format of INDs for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
- Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
- Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility
- Guideline for submitting documentation for the manufacture of and controls for drug products
- Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances
- Guideline for the format and content of the microbiology section of an application
- Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application
- Guideline for the monitoring of clinical investigations
- Manual del Centro para la Evaluacion e Investigacion de Farmacos
- Piénselo muy bien : una guía para el control de los beneficios y riesgos de las medicinas
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 10, polyacrylamide gel electrophoresis general chapter
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 9, tablet friability general chapter
- Q8(R1) pharmaceutical development revision 1
- Quality of biotechnological products : analysis of the expression construct in cells used for production of r-DNA derived protein products
- Reviewer guidance : conducting a clinical safety review of a new product application and preparing a report on the review
- Reviewer guidance : integration of study results to assess concerns about human reproductive and developmental toxicities
- Reviewer guidance : validation of chromatographic methods
- Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports
- S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- Structure and content of clinical study reports
- Studies in support of special populations, geriatrics
- A review of FDA's implementation of the Drug Export Amendments of 1986
- Animal models : essential elements to address efficacy under the animal rule
- Approved drug products with therapeutic equivalence evaluations
- Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products
- Dose-response information to support drug registration
- Drugs@FDA
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.law.upenn.edu/resource/YnqncGWbMHA/" typeof="Organization http://bibfra.me/vocab/lite/Organization"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.law.upenn.edu/resource/YnqncGWbMHA/">Center for Drug Evaluation and Research (U.S.)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.law.upenn.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.law.upenn.edu/">Biddle Law Library- University of Pennsylvania Law School</a></span></span></span></span></div>
