The FDA published a new batch of product-specific guidelines (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval. These new guidelines will help streamline generic ...
Compliance with food safety regulations and certifications (e.g., FDA, HACCP). Organic, Non-GMO, or other specific certifications, if applicable. Remember that these are the most common ones. We always suggest consulting with local authorities to find out local food safety requirements that apply...
They recommend using only FDA-approved drug products unless the patient has a specific medical need (e.g., an allergy) that cannot be met by the approved drug products. Because they do not go through the drug approval process, compounded drugs should only be used when an FDA-appr...
Instead of just asking people whether they like it or not, ask specific questions like, “Based on the design, what kind of product do you think is in this box?” and “If you saw this in your mailbox, would it make you smile?” The more information you can get, the better. 💡...
Medical Encyclopedia med·i·ca·tion (mĕd′ĭ-kā′shən) n. 1.A drug or other substance used to treat disease or injury; a medicine. 2.The act or process of treating a patient with medicine:the response to medication. American Heritage® Dictionary of the English Language, Fifth...
E.g., Cross-linked cellulose's Starch and Avicel have a specific shapes and morphology and maybe easily detected. Review FDA CDER Home page for listing and Biostudy parameters Dissolution profile Stage 8 USP monograph and FDA method - (where present) Dissolution; 12 unit Dissolution Profile. ...
(NMPA) of China released the "Guidelines for the Production Quality Management of Cell Therapy Products (Trial)" in October 2022. It recommends the adoption of continuous and closed production processes, the use of dedicated, product-specific, or disposable devices to minimize the risks of ...
“As a distribution leader, it is my role basically to ensure that we follow all our SOPs and quality guidelines. It is very important, everything from the maintenance of the temperature of our facility, including the cold box where we're standing in now, all the way through how ...
FDA Drafts Guidelines On How Risk Should Be Conveyed In Product AdsDavid Filmore
11 There are prescription moisturizers with specific ingredient ratios (eg, ceramides and free fatty acids) that are cleared by the US Food and Drug Administration (FDA) as medical devices. Whereas these products demonstrate clinical efficacy in controlled studies, they are significantly more expensive...