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The FDA is responsible for pprotecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US food supply, cosmetics, dietary supplements, and products that give off radiation.
A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.
Industry:Pharmaceutical
Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria:
* they are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
* they are assigned by FDA the same therapeutic equivalence codes starting with the letter "A ." To receive a letter "A", FDA
* designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD).
* assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).
Industry:Pharmaceutical
The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). Sample TE codes: AA, AB, BC.
* FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products. A drug product is deemed to be therapeutically equivalent ("A" rated) only if:
* a drug company's approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug.
* those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected.
* Some drug products have more than one TE Code.
* Those products which the FDA does not deem to be therapeutically equivalent are "B" rated.
Over-the-counter drugs are not assigned TE codes.
Industry:Pharmaceutical
縮寫的新藥物應用 (安達) 包含的資料，當提交到 FDA 的中心藥物評價和研究中心，泛型毒品辦公室提供審查和仿製藥產品的最終審批。通用藥物應用程式被稱為"縮寫"，因為他們通常不需要包括臨床前 （動物） 和臨床 （人類） 的資料，以確定安全性和有效性。相反，一個通用的 申請人必須科學地證明其產品是生物等效性 （即，在仿製藥相同的方式執行）。一旦獲得批准，申請人可能製造和市場仿製藥產品提供給美國公眾的安全、 有效、 低成本的替代。
Industry:Pharmaceutical
批准歷史是涉及一種藥物產品具有特定的 FDA 申請編號 (NDA) 的所有 FDA 操作的按時間順序清單。有超過 50 種的批准操作包括標籤、 管理和新的患者人群的藥物產品的新路線的變化。
Industry:Pharmaceutical
生物產品批准了公共衛生服務 (PHS) 法 》 的規定下的行銷。法 》 規定，如公司人製造生物出售的州際商務持有該產品的許可證。A 生物製劑許可應用程式提交包含特定資訊的製造流程、 化學、 藥理學、 臨床藥理學和醫學生物產品的影響。提供的資訊是否符合 FDA 要求、 申請獲得批准，頒發的許可證，允許該公司產品的市場。
Industry:Pharmaceutical
生物產品包括範圍廣泛的產品，如疫苗、 血液和血液成分、 allergenics、 體細胞、 基因治療、 組織和重組蛋白質藥物。生物製劑可由糖、 蛋白或核酸或複雜的組合，這些物質，或可能是生活等細胞和組織的實體。生物製劑是孤立的從各種天然來源 — — 人類、 動物或微生物 — — 和可能產生的生物技術方法及其他尖端科技。基因-基於和細胞生物製劑，例如往往處在最前沿的生物醫學研究，並可用於治療各種醫療條件沒有其他治療方法可用。
一般情況下，這一術語"藥物"包括治療生物產品。
Industry:Pharmaceutical
