Series 1:Drug Development requirements through the eyes of FDA

Step 1: Thinking about a product and planning to scroll through the guidance documents to file (Guidance Documents for Drug Applications)

Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.   They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.  Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.  An alternative approach may be used if this approach satisfies the requirements of the applicable statute, regulations, or both, for the complete list of CDER guidances.

Guidance Documents Drugs:-Investigational New Drugs (IND), Emergency INDs, New Drug Applications (NDA), Abbreviated New Drug Applications  (ANDA)

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Step 2: Thinking about a drug, you have to test it, evaluate health benefits, outweigh risks (Development & Approval Process)

The main consumer watchdog is the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). The center's best-known job is to evaluate new drugs before they can be sold. The center's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. A major step in the drug evaluation process before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests that is toxicity testing folowed by experimental studies to discover how the drug works and whether it's likely to be safe and work well in humans. A series of tests in people called as clinical trials begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.