federal pharm law ( food and drug administration )

CVM

1. REGULATE the maufacture and distribution of food additive and drugs that will be given to animals. - include animals from which human foods are derived sa well as food additives and drugs for pet (companion) animals. 1. RESPONSIBLE for regulating drugs, devices, and food additives given to, or used on over one hundred million companion, plus millions of poultry, cattle, swine, and minor animals species. ( such as cattle, swine, horses,dogs,cats,turkeys,chickens).

FDA PROCESS FOR RESPONDING TO DRUG APPLICATION

- CDER will no longer issue approvable or not appprovable letters when a drug application is not approved, instead CDER now issues a COMPLETE RESPONSE letter at the end of the review period to let a drug company know of the agency's decision on the application. 1. COMPLETE RESPONSE: letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. 2, THE LETTER: will DESCRIBE specific deficiencies and, when possibble, will outline recommended actions the applicant might take to get the application ready for approval.

CDER - Rx drugs

- Rx medicines must be administered under a doctors supervision or require a doctor's authorization for purchase. 1. disease or condition maybe serious and require a doctor's management. 2. same Sxm's can be caused by different disease that only a doctor can DX. 3. differenet causes may require different medicines 4. medicines can be dangerioys when used to treat the wrong disease 5. drugs can be abused.

CDER- generic drugs

- a generic drug is a chemical clone of drug sold under a brand name. 1. generic drugs often cost a/b 30% less than the brand-name drug. 2. FDA works with pharm companies to assure that all drugs marketed in the US meets specifications for identity, strength, quality, purity, and potency, BEFORE APPROVING a generic product. 3. REQUIRE many test and procedures to assure that the generic drug can be substituted for the brand name product. 4. drug products evaluated as " THERAPEUTICALLY EQUIVALENT" can be expected to have EQUAL effects and no difference when substituted for the brand name product.

NEW DRUG APPLICATION

- formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the US. a new drup application includes all animal and human data and analyses of the data, as well as info a/b how the drug behaves in the body and how it is manufactured. 1. when the NDA comes in, the FDA has 60 DAYS TO DECIDE WHETHER TO FILE it so that it can be reviewed. 2. accordance with Rx drug user fee act (PDUFA) the FDA's CDER expects to review and act on at least 90% of NDAs for standard drugs no later than 10 months after the applications are received. 3. REVIEW GOAL- is 6 months for priority drugs.there is also a continuous interaction throughout the review process.

CTP

- implement family smoking prevention and tobacco control act. 1. RESPONSIBILITIES under law - setting performance standards, reviewing premarket application for new and modified risk tobacco products, requiring new warning labels, and est. and enforcing advertising and promotion restriction.

FDA'S DRUG REVIEW PROCESS: ENSURING DRUGS ARE SAFE AND EFFECTIVE. ( investigational new drug application)

- investigational new drug application is the result of a successful pre-clinical development program. it is also a vehicle through which a sponsor advances to the next stage of a drug development ( clinical trials) 1. early pre-clinical development, sponsors PRIMARY GOAL to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. 2. when a product is a viable candidate, sponsor focuses on COLLECTING DATA and information necessary to est. that the product will not expose humans to unreasonable risks when used in limited, early stage clinical studies. 3. the IND is a request for an exemption from the federal statue that prohibits an unapproved drug from being shipped in interstate commerce. 4. CURRENT federal law requires - that a drug be the subject of an approved marketing application BEFORE it is transported or distributed across state lines. 5. the IND is the means through which a sponsor technically obtains this exemption from the FDA. however its MAIN PURPOSE- is to detail the data that provide documentation that it is indeed reasonable to proceed with certain human trials with the drug.

CDER ( the consumer watchdog for safe and effective drugs)

- perform an essential public health task by making sure that safe and effective drugs are available to improve the health of the people in US. 1. REGULATE OTC and RX drugs, including biological therapeutics and generic drugs. 2. EVALUATE new drugs b/f they can be sold. the center's review of new drug application not only prevents quackery but it provides doctors and patients with info they need to use medicine wisely. 3. ENSURE that drugs both brand - generic work correctly, health benefit outweigh the risk. EVALUATE benefit and risks of drugs and ENSURE that consumers have access quickly to new treatment.

CBER

- regulates biological products for human use under applicable federal laws. 1. PROTECT and advances the public health by ensuring that biological products are safe and effective and available to those who need them. 2. PROVIDES the public with information to promote the safe and appropriate use of biological products. 3. MISSION is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

CFSAN

- responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. 1. PROVIDE services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks, scientific analysis and support and policy, planning and handling of critical issues related to food and cosmetics.

CDRH

- responsible for regulating firms who manufacture, repackage, label, and/or, import medical devices sold in US. 1. REGULATES radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray, ultrasound equipment , microwave ovens and color televisions.

CDER- OTC products

- CDER oversees OTC drugs to ensure that they are properely labeled and that their benefit outweigh their risk. 1. OTC drugs characteristics- benefits outweigh their risks the potential for misuse and abuse is low consumer can use them for self-diagnosed conditions they can be adequately labeled. health practitioners are not needed for the safe and effective use of the products.

FDA'S DRUG REVIEW PROCESS: ENSURING DRUGS ARE SAFE AND EFFECTIVE( treatment IND)

- FDA will permit an investigational drug to be used under a treatment IND if there is will permit an investigational drug to be used under a treatment IND if there is a preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alt drug or therapy avaliable to treat that stage of the disease in the intended patient population. 1. treatment INDs are made avaliable to patients b/f general marketing begins, typically during PHASE 3 studies. treatment IND also allows FDA to obtain additional data on the drugs safety and effectiveness.

NCTR

- FDA's internationally recognized research center. in partnership with researchers, gov't agencies, academia, and industry. 1. PROVIDES innovative technology, methods development, vital scientific training, and technical expertise. 2. the UNIQUE scientific expertise of NCTR - is critical in supporting FDA product centers and their regulatory roles.

REVIEWING APPLICATION

- the official review time is the length of time it takes to review a new drug app and issue an action letter, an official statement informing a drug sponsor of the agency's decision. 1. once a NDA is filed, an FDA review team (medical doctors, chemists, statistcians, microbiologists, pharmacologists, and other exeperts) -- EVALUATE whether the studies the sponsor submitted show that the drug is safe and effective. - no drug is safe, in this sense benefit of the drug appears to outweigh the risks. 2. the review team ANALYZES study results and looks for possible issues with the application such as WEAKNESS of the study design or analyses. reviewers determine whether they agree with the sponsor's results and conclusions, or whether they agree with the sponsor's results and conclusions or if additional info is needed to make a decision. 3. each reviewer prepare written order evaluation containing conclusions and recommendations a/b the application. 4. EVALUATIONS are then considered by TEAM LEADERS. division directors and office directions. 5. reviewers receive training that FOSTERS consistency in drug reviews, and good review practice remain a high priority. 6. sometimes FDA calls on advisory committees made up of outside experts, who help the agency decide on drug application. if needed more so, would be it it's a srug that has significant questions, it its the first in it's class, or the first for a given indication.