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FDA's Drug Registration
Drug discovery is the process of discovering a new molecule and bringing it to the sector or public. Discovering a new molecule is a lengthy process, expensive, and certainly will be accomplished by pharmaceutical companies. Out of several thousands of new compounds, just a few will be considered for testing in people, and among those few, only one, i.e., the final product, will be approved and marketed. Drugs directly act on goal websites that are accountable…Continue
First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies and Pre-IND Meetings for a variety of submissions including new clinical uses of a marketed drugs (new indications), new formulations and fixed dose combination products. Moreover, PDG has had success in…Continue
The Food and Drug Administration (FDA) administers inspections and assessments are the regulated facilities used to determine a company's obedience with all the applicable laws and regulations, which are used in industries such as the Food, Drug, and Cosmetic Act and other related Acts.
FDA facility inspection normally discloses a large number of inspection information to the public to…Continue
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 effective to use only when they are prescribed by a doctor. However Non-prescription drugs are those which can be…Continue