The FDA issued 34 product-specific guidelines for the first oral botany BE recommendation

On November 18, the FDA released a new batch of 34 product-specific guidelines (PSGs) to guide generic drug development and support the evidence needed to simplify new drug applications (ANDA) approvals, helping to simplify generic drug development and FDA ANDA reviews.
, the FDA has released 1974 PSGs, and this year it has released more than 160.
this batch of 36 product-specific guides includes 13 additions and 21 revisions.
24 articles, 10 of which are complex products, are for products that have not yet been approved for ANDA.
11 (5 new, 6 revised) guidelines for complex products, 2 of which are based on research data generated by the GDUFA Science and Research Program.
's guidelines for the treatment of important diseases include: Attention to defective OMD ulcerative colitis hypertension FDA In a notice issued in this batch of PSG guidelines, the FDA's new guidelines for complex metered-dose inhaler (MDI) products containing epinephrine suspension (see listed product: Primatene Mist).
this is the first specific product guide for over-the-counter (OTC) MDI products that temporarily relieve mild asthma symptoms in adults and children over 12 years of age.
complex products are often difficult to develop by using traditional bioethics (BE) methods, so there are fewer generic products, resulting in less competition in the market for these products."
the guidelines recommend establishing bioethics through in-body BE studies, pharmacodynamic BE studies, comparable clinical physics BE studies, and other studies.
with the recommendations detailed in the new PSG, the FDA aims to make it easier for the public to access affordable generics, including complex products, by providing the industry with current scientific thinking about establishing BE between generic epinephrine metered-dose aerosol drug products and reference products.
the newly released guidelines also include PSG for Crofelemer, the fda-approved second prescription plant drug (the first prescription oral plant drug and one of the only FDA-approved plant drugs).
Mytesi was approved on 31 December 2012 for non-infectious diarrhea in adult HIV/AIDS patients treated with antiretroviral drugs.
FDA's guidelines provide recommendations for the identification and quality assessment of plant raw materials (BRM), recommendations for API similarity, recommendations for bioethics (research type is clinical endpoint biological ethnosoceability studies).
plant raw materials, the FDA noted that generic applicants should use the same plant species and perform a BRM assessment, including: 1. Crofelemer BRM should be collected from red latex coarse from Croton lechleri, Peru.
the correct identification and identification of plant species based on techniques such as macro/micro and/or genetic material analysis.
2. Coarse magenta latex as BRM should be collected from mature plants with clear ecological geo-growth areas (EGRs).
implementation and implementation of established Good Agricultural and Harvesting Practices (GACP) procedures will minimize BRM differences and ensure batch consistency between crofelemers.
3. The crofelemer content, total phenol and Tassin alkali content of BRM, as well as heavy metals and pesticides, should be analysed.
With regard to API similarity, the FDA recommends that generic applicants use the API to be tested and the API obtained from the Reference Product (RLD) for parallel comparison, and recommends that at least three batches of pending and RLD products be characterted to evaluate API similarity and robustness in the production process.
the FDA has proposed three criteria to demonstrate API similarity: 1. Crofelemer's chemical and chemical properties are quite 2. Chemical fingerprint map of Crofelemer compositions and other coexisting ingredients 3. Biometric results are comparable to the FDA's upcoming Product Guide for Complex Product Development page, which provides a list of specific product guidance for the FDA to release or revise for complex product programs over the next year, which is updated each time the FDA releases a new batch of guidance.
know the forest - pepper