FDA issues generic drugs 2019 summary 2020 outlook

Translation | pharmlink Huaping According to FDA, generic drugs account for more than 90% of us prescriptions, and safe, effective and high-quality generic drugs play a crucial role in the US medical system Affordable drugs are the top priority of public health, and generic competition can significantly reduce drug prices It is the first task of FDA to solve the high cost of drugs by making more drug competition enter the market The office of generic drugs (OGD) is dedicated to providing information and guidance on generic drug programs As part of FDA's commitment, in 2019, OGD will focus on policies that can accelerate the supply of generic drugs and help patients in the United States reduce prices Achievements in 2019 include a total of 1014 generic drugs getting final and preliminary approval, the FDA said Of these approvals, 110 are complex generic drugs that are difficult to develop and traditionally lack competition in the market Approved drugs include 108 first-line generic drugs, including those used to treat or prevent serious diseases such as pulmonary hypertension, breast cancer, seizures, stroke, depression and various infections The generic office also continues to improve the efficiency of generic drug development under the FDA's drug competition action plan (DCAP) and generic user fee amendment (GDUFA) programs A key part of DCAP and gdufa is to make generic approval easier by addressing possible scientific and regulatory challenges Anda application approved or temporarily approved: 1014 In 2019, 110 kinds of complex generic drugs were approved, accounting for 11% of the total approved generic products 269 product specific guidelines (PSGs), 4 new or revised industry specific guidelines, and 1 stakeholder specific policy and procedures manual (MAPP) were published 2311 complete response letters were sent detailing the important issues that the applicant needs to address before FDA approval In 2019, 105 anda meeting requests were received to discuss product development and / or pre submission issues More than 10000 external stakeholders attended six meetings and workshops Figure: approval or provisional approval of generic drugs month by month in 2019 In the generic innovation research project, FDA funded 14 new research contracts and awarded 3 awards These contracts and awards are in line with FDA's current regulatory science focus to help advance the development of generic drugs and their safe and effective use In one of these research projects, the winners will explore the development of models and bioequivalence assessment strategies for long-term injections to help ensure that the imitated versions of long-term injections are the same as the original products In another project, the winner will develop and implement a novel data tool based on text analysis and machine learning.