Subject NDA definition

Subject NDA means NDA 205750 for CHOLBAM (Cholic Acid) Capsules, 50mg and 250mg.
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Subject NDA means New Drug Application (“NDA”) Number 213793, approved by the FDA on November 25, 2020 for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
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Subject NDA means NDA No. 208627 approved on July 13, 2018 with respect to TPOXX® (tecovirimat) capsules, 200 mg, for the treatment of patients with human smallpox disease caused by variola virus.
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Examples of Subject NDA in a sentence

  • Kind regards, Joanne From: Markos, Constantine [mailto:Constantine.Markos@fda.hhs.gov] Sent: Wednesday, February 24, 2010 2:37 PM To: Lemmo_Joanne Subject: NDA 022548 - Gatifloxacin Ophthalmic Solution 0.5% - Allergan, Inc.

  • O’Donnell, MPHRegulatory Review OfficerOffice of Prescription Drug Promotion (OPDP) Subject: NDA 205831APTENSIO XR™ (methylphenidate hydrochloride) Extended-Release Capsules, CII OPDP has reviewed the draft product labeling (PI) and Medication Guide (MG) for APTENSIO XR™ (methylphenidate hydrochloride) Extended-Release Capsules, CII (Aptensio XR) requested in the consult from DPP dated August 26, 2014.

  • From: Laura Musse, RN, MS, CRNP Regulatory Health Project ManagerDivision of Pulmonary, Allergy, and Rheumatology ProductsFax number: 610-786-7051 Fax number: (301) 796-9728 Phone number: 610-727-6125 Phone number: (240) 402-3720 Subject: NDA 207921 (beclomethasone dipropionate) Information Request for labeling Total no.

  • SO.17: Business continuityThe business continuity plan ensures the continuity of the services offered.

  • Shenee Toombs, Regulatory Review Officer (OPDP)CC: Olga Salis, Senior Regulatory Health Project Manager (OPDP) Michael Wade, Regulatory Health Project Manager (OPDP) Subject: NDA 207233OPDP labeling comments for Vivlodex (meloxicam) capsules, for oral use Labeling Review OPDP has reviewed the proposed package insert (PI) and carton/container labeling for Vivlodex (meloxicam) capsules, for oral use (Vivlodex) that was submitted for consult on May 11, 2015.

  • E M O R A N D U M DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATIONCENTER FOR DRUG EVALUATION AND RESEARCH Date: March 1, 2010 To: Bob Rappaport, M.D., DirectorDivision of Anesthesia, Analgesia and Rheumatology Products Thru: Michael Klein, Ph.D., Director Controlled Substance Staff (CSS) From: Silvia Calderon, Ph.D., Team Leader Controlled Substance Staff (CSS) Subject: NDA 21-217, Exalgo/Hydromorphone HCl Extended Release, 8 mg, 12 mg, 16 mg, 32 mg tablets.

  • Medical Officer, ODE III, DDDP David Kettl, MDClinical Team Leader, ODE III, DDDP From: Celestina Arowosegbe, Pharm.D.Regulatory Review OfficerOffice of Prescription Drug Promotion (OPDP) Subject: NDA 204286NAFTIN (naftifine hydrochloride) Gel, 2% for topical use Package Insert (PI) As requested in your consult dated October 1, 2012, OPDP has reviewed the draft PI for NAFTIN (naftifine hydrochloride) Gel, 2% for topical use.

  • In the GLV this becomes obvious if you look at the difference equation (1.3o), which can be seen as either a way of multiplying the variables (a multiplicative process) or a way of modelling two different growth rates (double exponential process).

  • I also expect the soil and geology underlying different vegetation communities such as grassland, open or closed woodland to differ depending on the clay fraction and the topographical position of the vegetation community in the landscape.

  • Jones, Regulatory Review Officer Office of Prescription Drug Promotion (OPDP) Subject: NDA 206073OPDP labeling comments for GLYXAMBI® (empagliflozin and linagliptin) tablets, for oral useOPDP has reviewed the proposed draft prescribing information (PI) and carton container labels for GLYXAMBI® (empagliflozin and linagliptin) tablets, for oral use (Glyxambi) submitted for consult on January 6, 2015.


More Definitions of Subject NDA

Subject NDA means NDA 206488 for Exondys 51 (eteplirsen) Injection, 50mg per mL.
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Subject NDA means New Drug Application (“NDA”) Number 215498, approved by the FDA on July 20, 2021 for BYLVAY (odevixibat) capsules and oral pellets for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC).
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Subject NDA means NDA Number 215904, approved by the FDA on March 18, 2022 for the use of Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients 2 years of age and older.
Sample 1

Related to Subject NDA

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Subsurface tracer study means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.