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Historical Aspects ,[object Object],of ,[object Object],New Drug Approval Process,[object Object],Prepared by:,[object Object],Paresh K Bharodiya,[object Object],09pct07,[object Object],Guided by:,[object Object],Mr. Dharmesh. M. Modi,[object Object],Department of pharmaceutics,[object Object],A.R College & G.H Patel Institute of Pharmacy,[object Object],2009-10,[object Object],1,[object Object]
2,[object Object]
New drug Approval.,[object Object],[object Object]
The  Center for Drug Evaluation and Research (CDER) is the arm of the FDA that, as its name suggests, evaluates new drugs before they are sold.
This process requires multiple levels of research to make sure that medications are safe and effective before they are made available to the public. And that takes time and money3,[object Object]
Overview of the drug approval process,[object Object],Drug development can generally be divided into phases.,[object Object],The Preclinical phase,[object Object],Clinical phases,[object Object],4,[object Object]
Clinical,[object Object],Phases ,[object Object],Preclinical,[object Object],Phase ,[object Object],Phase 1,[object Object],Phase 2,[object Object],Phase 3,[object Object],100-300,[object Object],patients,[object Object],1000-3000 patients,[object Object],20-100 ,[object Object],volunteers,[object Object],Laboratory ,[object Object],&,[object Object],Animal study,[object Object],subjects,[object Object],File  NDA,[object Object],Verify effectiveness. long term side effects,[object Object],Purpose ,[object Object],Safety &,[object Object],Dosage ,[object Object],Effectiveness.,[object Object],Side effects,[object Object],Access safety & ,[object Object],Biological activity,[object Object],File IND,[object Object],Time,[object Object], corse,[object Object],4-5years,[object Object],1-2 years,[object Object],3-4 years,[object Object],6-8 years,[object Object],New ,[object Object],drugs ,[object Object],pass ,[object Object],33 %IND,[object Object],27 %,[object Object],70 % of IND,[object Object],100 %,[object Object],5,[object Object]
FDA Review andApproval,[object Object],After phase III, the pharmaceutical company prepares reports on all studies conducted on the drug and submits the reports to the FDA in a New Drug Application (NDA).,[object Object],The FDA then reviews this information to determine whether the drug is safe and effective for its intended use. If the drug passes this review, it is approved for use.,[object Object],6,[object Object]
 A Historical Perspective of drug regulation and approval,[object Object],At the turn of the 20th century, there were no federal regulations to protect the public from dangerous drugs,[object Object],Misfortune, disaster, and tragedy have triggered most of the advances in drug regulation,[object Object],7,[object Object]
The First Federal Drug Law,[object Object],The original Pure Food and Drugs Act was passed by Congress in 1906 and signed by President Theodore Roosevelt.,[object Object],concerns about worthless or even dangerous medicines led to the enactment of the Food and Drug Administration Act of 1906.,[object Object],This law,[object Object],Required that drugs meet official standards of strength and purity,,[object Object],Defined the terms adulterated and misbranded, and,[object Object],Prohibited the shipment for sale of misbranded and adulterated foods, drinks, and drugs,[object Object],8,[object Object]
Limitations of the first federal drug  law,[object Object],There was norequirement that any information be submitted to the FDA before marketing ,[object Object],the law required only that drugs meet standards of strength and purity,[object Object],The burden of proof was on the government to show that a drug's labeling was false and misleading before it could be taken off the market.,[object Object],9,[object Object]
Sherley Amendment in 1912 ,[object Object],US v Johnson case,[object Object],The act did not prohibit false therapeutic claims, only false claims about ingredients. ,[object Object],Sherley Amendment - 1912 ,[object Object],specifically prohibits false claims,[object Object],10,[object Object]
The Food, Drug, and Cosmetic Act of 1938,[object Object],Revised legislation wasn't passed until 107 people died from a poisonous  ingredient in Elixir Sulfanilamide. The S.E. Massengill Co. of Bristol, Tenn.,[object Object],As a consequence of this event, Congress passed the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938 with new provisions,[object Object],11,[object Object]
manufacturers were required to show that a drug was safe before it could be marketed.,[object Object],Manufacturers had to submit an application to the FDA before marketing a drug. If the FDA didn't act on the application in a certain time period, the application automatically became  approved.,[object Object],The 1938 act also eliminated the Sherley Amendment, which called for adequate labeling for safe use,[object Object],set safe tolerances for unavoidable poisonous substances, and authorized factory inspections,[object Object],This mandate for premarket evidence of a drug's safety represented the birth of the new drug application, or NDA.,[object Object],12,[object Object]
Durham-Humphrey Amendment, In 1951,[object Object],Following the 1938 Act, the FDA began to distribute public notices (known as trade correspondences) to the industry regarding the labeling and dispensing of drugs,[object Object],It was in these public notices that the FDA first distinguished medications that should be available only by prescription,[object Object],At this point the decision about which drugs should receive a caution label was largely at the discretion of the manufacturer.,[object Object],In 1951, the Durham-Humphrey Amendment set forth the basis for distinguishing between prescription and nonprescription drugs.,[object Object],13,[object Object]
The DH amendments gave FDA the responsibility to clarify which drugs are:,[object Object],Habit-forming,,[object Object],Not safe except under a practitioner’s supervision, and,,[object Object],Drugs limited to prescription sale as part of the approval of a New Drug Application.,[object Object],Required “Caution: Federal Law Prohibits Dispensing Without a Prescription.” (Today “Rx Only”.) ,[object Object],Prescription exemption (for manufacturers),[object Object],Pharmacists must label prior to dispensing.  ,[object Object],14,[object Object]
The Kefauver-Harris Drug Amendments,[object Object],In 1961, an Australian obstetrician, William McBride, reported an increase of fetal malformations in association with the hypnotic drug thalidomide.,[object Object],Although thalidomide,[object Object],was heavily marketed in ,[object Object], 	Western Europe, approval,[object Object], 	of this drug was delayed,[object Object],	 by the FDA in the United ,[object Object],	States and never made it to ,[object Object],	market,[object Object],In October 1962, Congress ,[object Object],passed the Kefauver-Harris,[object Object],Drug Amendments to the,[object Object],Federal FD&C Act,[object Object],15,[object Object]
As per this amendments,[object Object],Before marketing a drug, firms now had to prove not only safety, but also provide substantial evidence of effectiveness for the product's intended use,[object Object],Kefauver-Harris Drug Amendments also asked the Secretary to establish rules of investigation of new drugs, including a requirement for the informed consent of study subjects.,[object Object],The amendments also formalized good manufacturing practices,,[object Object],required that adverse events be reported, ,[object Object],and transferred the regulation of prescription drug advertising from the Federal Trade Commission to the FDA.,[object Object],16,[object Object]
In 1981, ,[object Object],formal standards for the Protection of Human Subjects and,[object Object],Institutional Review Boards (IRBs) were strengthened. ,[object Object],The IRBs are panels of scientists and non-scientists in hospitals and research institutions who ensure the safety and well-being of human subjects involved in research,[object Object],17,[object Object]
Anti-Tampering Regulations 1982,[object Object],After seven people in Chicago died from swallowing Tylenol capsules laced with cyanide, the FDA issued Tamper-Resistant Packaging Requirements in 1982. The Federal Anti-Tampering Act, passed in 1983, makes it a crime to tamper with packaged consumer products.,[object Object],18,[object Object]
1983 - “Orphan Drug Act,[object Object],the Orphan Drug Act (ODA) was passed in 1983,[object Object],It allowed the FDA to encourage research and development of drugs needed to treat rare diseases,[object Object],The ODA created financial incentives, including tax credits for the costs of clinical research and,[object Object],seven years of marketing exclusivity for the first sponsor of an orphan product who receives FDA approval for a particular indication,[object Object],Examples of rare diseases that can now be treated with orphan medications include sickle cell anemia, cystic fibrosis, and T-cell lymphoma.,[object Object],19,[object Object]
Encouraging Generic Drugs1984 - “Drug Price Competition and Patent Term Restoration Act’’,[object Object],Expanded the number of drugs for which an abbreviated new drug application (ANDA) could be submitted.,[object Object],Generic drug companies don't have to repeat the expensive clinical trials that brand companies have already conducted to show safety and effectiveness,[object Object],But they must perform tests and show the FDA that their drugs are equivalent to the brand name in terms of therapeutic effect.,[object Object],20,[object Object]
Drugs for Life-Threatening Illnesses,[object Object],In 1987, partially in response to the human immunodeficiency virus (HIV) epidemic, new regulationswere developed to accelerate approval for high-priority medications.,[object Object],Another example of improving access to treatment is "accelerated approval," which was formalized in 1992,[object Object],This type of drug approval is based on an encouraging effect such as tumor shrinkage, before there is actual evidence of improved survival or other clinical benefit,,[object Object],The FDA approves a drug under accelerated approval on the condition that the drug manufacturer verify the actual clinical benefit.,[object Object],21,[object Object]
The Prescription Drug User Fee Act,[object Object],The Prescription Drug User Fee Act (PDUFA) was passed in 1992, and mandated that drug companies pay user fees so the FDA could add more resources and speed up drug review times, without compromising standards.,[object Object],22,[object Object]
The Food and Drug Modernization Act of 1997,[object Object],In 1997, the PDUFA was renewed under the Food and Drug Administration Modernization Act and then renewed again in 2002 for five more years,[object Object],In addition, the Food and Drug Modernization Act (FDAMA) supported accelerated approval and gave an extra period (six months) of marketing exclusivity to manufacturers that carried out studies in children.,[object Object],23,[object Object]
Expanding Demographics in Clinical Trials,[object Object],In the 1980s and 1990s, several FDA guidance's and rules drew attention to the need to include representative populations in clinical trials,[object Object],The inclusion of such populations has helped experts analyze results for possible differences in drug response among demographic subsets.,[object Object],Here are some key changes that have helped expand demographic evaluation in drug research:,[object Object],24,[object Object]

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