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PubMedDate not supplied

First inhaled insulin product approved.

There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration's approval of the first-ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s.

Administration, Inhalation↗
PubMed1990

An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.

The history, purpose, and content of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") are described. When cost guidelines established in the 1970s for Medicare reimbursement prompted most states to permit generic drug product selection, an official list of interchangeable drug products was needed. Regulations for determining bioavailability and bioequivalence were published in 1977, and FDA first published Approved Drug Products in 1980. The Orange Book includes products that have been fully reviewed by FDA for both safety and effectiveness and for which new drug applications (NDAs) or abbreviated new drug applications (ANDAs) and special applications (From 5s or 6s) for antibiotics have been approved. Pursuant to the 1984 Drug Price Competition and Patent Term Restoration Act, FDA added approved nonprescription products to the Orange Book along with information about patents and periods of marketing exclusivity. Orphan drug products and certain testing and application procedures are also provided. Equivalence evaluations are provided in the Orange Book only for multisource prescription drug products that contain the same active ingredients and can be expected to have the same clinical effect when administered to patients under the conditions specified in the labeling. A coding system is used to indicate the products' equivalence evaluations according to FDA criteria, and indexes by product name and manufacturer are included. Monthly Cumulative Supplements are issued. The Orange Book contains public information and advice, but it is not an official national compendium; FDA has no position on state regulation of drug product selection by pharmacists. The equivalence evaluations do not relieve practitioners from exercising care in prescribing and dispensing products according to patients' individual needs.

Drug Information Services↗
PubMed1999

Regulation of food and drugs in the Philippines.

The regulation of food and drugs in the Republic of the Philippines is enshrined in the 1987 Philippine Constitution. Statutory laws are also in place providing legal basis for the creation of a regulatory agency, the Bureau of Food and Drugs, mandated to ensure the safety, efficacy and good quality of all food and drug products being made available to the general public. The most important of these laws are Republic Act (RA) 3720 "Foods, Drugs, Medical Devices and Cosmetics Act", RA 6675 "Generics Act", RA 8203 "Act Prohibiting Counterfeit Drugs", and RA 7394 "Consumers Act." Regulation is achieved through inspection and licensing of food and drug establishments, registration and market monitoring of products, approval of product label prior to marketing, and approval and monitoring of promotions and advertisements. International standards and guidelines such as those recommended by the WHO, USP or BP, FAO and Codex Alimentarius are used as a basis in the formulation and implementation of rules and regulations governing the manufacture, importation, exportation, distribution, or sale of food and drugs. Compliance with the requirements of good manufacturing practice is the basis criterion for licensing food and drug establishments, while safety, efficacy and good quality are the criteria for registration of products. Although cigarettes are not regarded as food or drug, the labeling and promotion of such is being regulated by the Bureau because of the hazard posed to public health.

Drug and Narcotic Control↗
PubMed2006

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.

Clinical Trials as Topic↗
PubMed1997

Drug patent expirations and the speed of generic entry.

OBJECTIVE: Using recent data, to analyze the generic drug entry phenomenon to determine the factors that influence the speed and likelihood of generic drug entries. DATA SOURCES: Data for 81 drugs that have lost patent between 1987 and 1994. Patent and exclusive marketing rights expiration dates: Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations (1986-1989). Generic entry dates: FDA Drug and Device Product Approvals (Jan. 1987-Dec. 1994). Numbers of pending generic applications: FDA Office of Generic Drugs Quantitative Report-ANDAs and AADAs (Nov. 1990-Jan. 1993). Sales revenue: Pharmaceutical Data Services, Walsh-America. STUDY DESIGN: This study appropriately recognizes generic entry as a survival problem, and uses a proportional hazard method for analysis. PRINCIPAL FINDINGS: (1) There is a negative relationship between an innovative drug's sales revenue and the time to generic entry. (2) Entries of generics tend to be slower for drugs that have either very few or a very large number of competing brands in the marketplace. (3) The time to generic entry increased overall between 1987 and 1994. (4) Drugs that primarily treat chronic symptoms tend to enter faster than the types of drugs that primarily treat acute illnesses. CONCLUSIONS: The analysis shows that the generic industry is targeting large-revenue products and chronic drug markets. Entry of a generic drug is influenced by the existing branded substitutes in the marketplace. Surprisingly, the generic drug entry process has slowed despite many changes that would facilitate entry.

Drug Industry↗