The news regardless of the topic, the day, the place where you live; they have great importance for people’s lives, it is given by the set of communication media that inform us about the most outstanding events. Thanks to the news we can know which route to take towards our work, know when it is…
The 505 (b) (2) application is one of three established types of regulatory submissions and may favor pharmaceutical sponsors. The FFDC defines the statutory submission of 505 (b) (2) as an NDA that includes a safety and efficacy investigation, most of which requires applicants to approve such an NDA. An applicant who is an applicant…
Not all inputs or raw materials have the same importance, and depending on specific needs, each company may emphasize certain standards and not others. According to your needs it is must to have good Drug supplier selection. But in addition to this, having the right suppliers allows you to have certain control over production costs…
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.…
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…