New Drugs definition

New Drugs means (1) any drug the composition of which is such that said drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety, efficacy, and quality of drugs as safe, efficacious and of good quality for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug the composition of which is such that said drug, as a result of its previous investigations to determine its safety; efficacy and good quality for use under certain conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under new conditions.
New Drugs means (1) any drug the composition of which is such that said drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety, efficacy, and quality of drugs as safe, efficacious, and of good quality for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug the
New Drugs means one which is not registered for free and open sale in Bangladesh)

Examples of New Drugs in a sentence

  • Please also contact the (b)(2) review staff in the Immediate Office, Office of New Drugs.

  • Comments from Other Review Disciplines: DMEPA requests the Office of New Drugs (OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their comments or concerns with the proposed proprietary name, ask for any clinical issues that may impact the DMEPA review during the initial phase of the name review.

  • If “NO”, please contact the (b)(2) review staff in the Immediate Office, Office of New Drugs.

  • If you believe there is reliance on a listed product that has not been explicitly identified as such by the applicant, please contact the (b)(2) review staff in theImmediate Office, Office of New Drugs.

  • Marketing certificate may be exempted for New Drugs as defined under the definition ofRule 2(w) of New Drugs and Clinical Trials Rules, 2019 except sub clause in Drug & Cosmetics Rules, 1945 except explanation made therein sub clause (iv) & (v) of the said rules.

  • Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People With AIDS and other HIV-Related Diseases, 57 Fed.

  • Is this application for a recombinant or biologically-derived product and/or protein or peptide product OR is the applicant relying on a recombinant or biologically-derived product and/or protein or peptide product to support approval of the proposed product?YES NO If “YES “contact the (b)(2) review staff in the Immediate Office, Office of New Drugs.

  • Natural Products as Sources of New Drugs over the Nearly Four Decades from 01/1981 to 09/2019.

  • I agree to inform all trial subject, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent and ethics committee review and approval specified in the New Drugs and Clinical Trials Rules, 2019 and Good Clinical Practices guidelines are met.

  • Salbu, The FDA and Public Access to New Drugs: Appropriate Levels of Scrutiny in the Wake of HIV, AIDS, and the Diet Drug Debacle, 79 B.U. L.


More Definitions of New Drugs

New Drugs means and include –

Related to New Drugs

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Prescription drugs means drugs, medicine and controlled substances which by law can only be prescribed for human use by persons authorized by law.

  • Covered drug means any prescription drug that:

  • Prescription drug means any drug required by federal law or regulation to be dispensed only

  • Legend drugs means any drugs which are required by state

  • New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

  • Nonprescription drugs means nonnarcotic medicines or drugs which may be sold without a prescription and are prepackaged and labeled for use by the consumer in accordance with the requirements of the statutes and regulations of this state and the federal government;

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • Drug addiction means a disease characterized by a

  • Nonprescription drug or "over-the-counter drug" means any

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • Therapeutically equivalent drug products means drug products that contain the same active

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • controlled drug means an article or substance prescribed under a regulation to be a controlled drug.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Specialty Drugs means drugs listed on the Approved Drug List meeting certain criteria, such as:

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Food and food ingredients means substances, whether in liquid, concentrated, solid, frozen, dried, or dehydrated form, that are sold for ingestion or chewing by humans and are consumed for their taste or nutritional value. Food and food ingredients do not include alcoholic beverages and tobacco.

  • Cosmetic Surgery means any Surgery, service, Drug or supply designed to improve the appearance of an individual by alteration of a physical characteristic which is within the broad range of normal but which may be considered unpleasing or unsightly, except when necessitated by an Injury.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).