The Food and Drug Administration (FDA) has several FDA drug labeling requirements and regulations that various industries must comply with. In June 2006, a new final FDA regulation, “Prescription Drug and Human Biological Product Content and Format Labeling Requirements,” came into effect. This rule is part of the FDA’s initiative to manage the risk of…
During the development of a new drug, sponsors will show whether the product is safe for early human use and the pharmacologically and clinically relevant activity of the compound that requires further investigation for future commercial growth. If you need any help, the IND consultant will work with or play a role in the Chief Regulatory…
The Food and Drug Administration (FDA) in the US requires that all Dietary Supplements be regulated by the Dietary Supplements Health and Education Act of 1994. Manufacturers of the product must ensure that they make sure your products are safe and accurately labeled. The FDA can take action against any manufacturer selling a product that…
In the U.S., every drug producer and manufacturer have to register in the FDA (FOOD AND DRUG ADMINISTRATION) before selling it to the market; we term this as Establishment Registration in FDA. Registration in the FDA means the FDA is aware of the medicines, medical devices, drugs, and other related product consumption by its people…
Although all countries have a different regulatory procedure for new drug approval and market a particular drug worldwide, the drug has to pass through the Marketing Authorization Application (MAA) of different countries. As USA plays an essential role worldwide in distribution and marketing drugs, one should know NDA Regulatory Services and its rules in USA.…
Because of the thalidomide tragedy in the U.S., the FDA (FOOD AND DRUG ADMINISTRATION introduced in 1940, GMP (GOOD MANUFACTURING PRACTICES). In 1963, the World Health Assembly supported CGM and stated that all companies, factories should follow GMP. In 1978, GMP was modified to CGMP and regulated by the FDA. CGMP works to ensure a…
Introduction Post marketing surveillance of drugs is an important part of the FDA. Whenever a drug is released in the market, it has to be monitored to see how people are doing after taking the drug. This helps keep them regulated safely, and they also provide further studies. These studies give further insight into how…
Non-prescription drugs are commonly known as over the counter medicines (OTC). These drugs can be bought from a retailer without any prescription. FDA decides which treatments need a prescription and which can be purchased over the counter. Now let’s see the difference between prescription and non-prescription drugs. Prescription medicines are those which are safe and…
Introduction: The diagnostic products, including drugs, devices, and biological products, are commonly referred to as Combination drug products. Combination products generally contain components that are typically regulated by different types of regulatory authorities. These products also face different kinds of challenges by various FDA centers regarding regulation, policy, and review management. The regulatory processes can…
Clinical research refers to the field of science, which can be used in determining the safety and efficacy of healthcare products. This kind of research is beneficial in the relief, treatment, and prevention of various diseases. Good clinical practices allows for the best interpretation of results to establish procedures in the best use of products…