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…
Medical products, even though the solution to many ills, have also been revealed as a possible source of adverse events or side effects. The role of Pharmacovigilance consultants is the recognition of drug or device risks, whether caused by quality defects, by intrinsic toxicity of the product, by idiosyncratic reactions of the individual, or by…
In the era of competition and globalization the demand for Regulatory Affairs Services are increasing rapidly. These services having a deep connection with health care sectors such as those dealing with the new SARS pandemic. Small-scale as well as big-scale companies are contracting these services through consultants on an everyday basis. Many types of companies…
In this development federation products are gathering pace, with lots of the worldwide pharmaceutical business raising them as a solution division of their latest product in the works. In various cases, firms clean off their elder drugs and produce new brain property around the newest rescue technology. New vaccination technologies, lesser combination pumps, and smarter…