Study Set Content:
FDA responds to IND applications in one of two ways:
Approval to begin clinical trials
Clinical hold to delay/stop investigation:
is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.
A clinical hold
responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.
The developer
m thoroughly examines submitted data on the drug and makes a decision to approve or not.
FDA Drug Review
can only be truly tested over the months and even years that make up a product’s lifetime in the marketplace
product’s safety
reviews reports of problems with prescription and OTC drugs and decide to add cautions to the dosage/ usage information, as well as other measures for more serious issues.
FDA
food, drugs, cosmetics, devices, biologicals, vaccines, diagnostic reagents, household/hazardous substances or a combination and/or a derivative thereof. It shall also refer to products that may have an effect on health which require regulations as determined by the FDA.
Health products
means any processed substance which is intended for human consumption and includes drink for man, beverages, chewing gum and any substances which have been used as an ingredient in the manufacture, preparation or treatment of food.
Food
Drug means;
Articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA;
Articles intended for use in the diagnosis, cure, migration, treatment, or prevention of disease in man or other animals;
articles (other than food) intended to affect the structure of any function of the body of humans or animals
articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories.
articles intended to be rubbed, poured, sprinkled or sprayed on, introduce into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and 2) articles intended for use as a component of any such articles.
cosmetics
can be medical devices, radiation devices & health-related devices.
Device
means any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings for one or more of the specific purposes
) Medical device
means an electrical or electronic apparatus emitting any ionizing or non-ionizing electromagnetic or particulate radiation; or any sonic, infrasonic, or ultrasonic wave. It includes ionizing radiation emitting equipment, which is not intentionally designed to produce radioactive materials
Radiation device
means any device not used in health care but has been determined by the FDA to adversely affect the health of the people.
Health-related device
are reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its seque
In-vitro diagnostic reagents
Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizer, pesticide, and insecticide and other economic poisons, radioactive substance, or substances intended for use as fuels, coolants, refrigerants and the like;
Household/urban hazardous substance
Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard; and
Household/urban hazardous substance
this term shall not apply to food, drugs, cosmetics, devices, or to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which is a hazardous substance, as construed in paragraph (1) of this section, by reason of bearing or containing such harmful substances described therein.
Household/urban hazardous substance
Serves as a member of policy-making committees (Pharmacy and Therapeutics Committee), including those concerned with drug selection, the use of antibiotics, and hospital infections and thereby influences the preparation and composition of an essential-drug list or formulary; • Educate other health professionals about the rational use of drugs; • Participates in studies to determine the beneficial or adverse effects of drugs, and is involved in the analysis of drugs in body fluids • Control hospital manufacture and procurement of drugs to ensure the supply of high-quality products; • Planning and implementation of clinical trials. • Review all medication orders • Prepare all medication and endorse to the nurse • Educate health provider colleague • Ensure patient medication adherence • Provide pharmacist intervention when necessary
Hospital pharmacy
Work with patient on general health • Processing of prescription • Health promotion • Dispense prescription • Counsel and educate patients • Ensure patients’ medication safety • Monitoring of drug utilization • Manage staff • Perform administrative tasks • Communicate with prescribers • Educate health provider colleagues
Community Pharmacy
