U.S. FOOD AND DRUG ADMINISTRATION
The Center for Drug Evaluation and Research (CDER)
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
http://www.fda.gov/Drugs/default.htm
Manual of Policies & Procedures (CDER)
CDER’s Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. MAPPs are required by law, and made available to the public to make CDER a more transparent organization.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm
FDA Guidance Documents
Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Drugs@FDA
Drugs@FDA allows you to search for official information about FDA approved innovator and generic drugs and therapeutic biological products. The main uses of Drugs@FDA are:
- finding labels for approved drug products
- finding generic drug products for an innovator drug product
- finding therapeutically equivalent drug products for an innovator or generic drug product
- finding consumer information for drugs approved from 1998 on
- finding all drugs with a specific active ingredient
- viewing the approval history of a drug
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Drugs@FDA Glossary of Terms
http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
Dissolution Methods Database
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.
http://www.fda.gov/Drugs/InformationOnDrugs/ucm135742.htm
OFFICE OF GENERIC DRUGS
The Office of Generic Drugs (OGD) is responsible for providing regulatory oversight to expedite the availability of safe, effective, and high-quality generic drugs to patients. We also provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters relating to generic drugs.
http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm119100.htm
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA. To provide timely consumer information on generic drugs, the Electronic Orange Book is updated daily as new generic approvals occur.
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Product-Specific Recommendations for Generic Drug Development
Individual Product Bioequivalence Recommendations
To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use, bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.
To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm
ICH – INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH’s mission is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.
http://www.ich.org/home.html
U.S. PHARMACOPEIAL CONVENTION (USP)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
http://www.usp.org/
CODE OF FEDERAL REGULATIONS
Electronic Code of Federal Regulations
The Electronic Code of Federal Regulations (e-CFR) is a currently updated version of the Code of Federal Regulations (CFR). It is not an official legal edition of the CFR. The e-CFR is an editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration’s Office of the Federal Register (OFR) and the Government Publishing Office. The OFR updates the material in the e-CFR on a daily basis.
http://www.ecfr.gov/
CLINICALTRIALS
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
https://clinicaltrials.gov/
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
PhRMA, the Pharmaceutical Research and Manufacturers of America, represents the country’s leading biopharmaceutical researchers and biotechnology companies.
http://www.phrma.org/
GENERIC PHARMACEUTICAL ASSOCIATION
The Generic Pharmaceutical Association (GPhA) is the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.
http://www.gphaonline.org/
AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS (AAPS)
American Association of Pharmaceutical Scientists (AAPS) members primarily come from a pharmaceutics, biopharmaceutics, or pharmacy field of study. AAPS members also represent those scientists from complimentary disciplines, such as chemistry, biology, engineering, and medicine, involved in the discovery, development, and manufacture of pharmaceutical products and therapies.
http://www.aaps.org/
