2018 US FDA approval report on generic drugs: more than 1000 first generic drugs approved, accounting for 10%

The U.S Food and Drug Administration's office of generic drugs (OGD) this week released its 2018 annual report on generic approval, highlighting that 2018 is another landmark year for generic approval and new guidance documents In the report, FDA OGD lists many achievements in 2018 and the first year of implementation of gdufa II, including: 1 1021 new drug simplification applications (andas) were approved or temporarily approved, 14% of which were complex generic drugs; 10% of which were first generic drugs, 18% of which were complex generic drugs 2 More than 250 new or revised guidance, product specific guidance (PSG), policy and procedure manual (MAPP) were issued 3 Successfully implemented many new regulations in gdufa II and FDA reauthorization act 2017 (fdara), including pre anda meeting request, reconsideration request, one-time update of sales status of orange peel book, competitive generic drug (CGT) identification, exclusive request, etc 4 Continue to promote the establishment of a strong generic pipeline by conducting and sharing regulatory scientific research, issuing guidance, and responding to controlled letters in a timely manner 5 Maintain a repeatable high-capacity and high-quality approval output 6 Create a dynamic communication process, providing the industry with higher transparency and predictability 7 Launched a new online function to receive enterprise controlled letter queries, and responded to about 700 such queries through the direct NextGen collaboration portal of the center for drug evaluation and Research (CDER) 8 2648 complete response letters (CRLs) were issued, detailing important issues that the applicant needs to address before FDA approval In terms of approval of generic drugs, FDA considers the approval of first generic drugs of brand drugs as a public health priority, and accelerates the review of such applications In 2018, the important first generic drugs approved by FDA include: the approval of generic drugs in 2018 (a record in October and November); the approval of generic drugs in 2018: 211 temporary approvals and 810 full approvals In 2018, OGD released 6 draft guidelines, 4 final guidelines and 2 policy and procedure manuals (MAPPS) As part of its efforts to make the generic review process more transparent, OGD published a draft Industry Guide, the good anda submission practices, detailing common deficiencies in Anda that may cause delays in approval In addition, OGD has issued a MAPP called good anda evaluation practice, which outlines the Anda evaluation practices of OGD and the office of drug quality, and formally identifies several improvements in the efficiency of Anda evaluation to accelerate the approval of qualified generic drugs For other details of the FDA's 2018 generic drug approval report, please refer to: 2018 Office of generic drugs (OGD) annual report (Sina pharmaceutical compilation / newborn) article reference source: 1 2018 in generic drugs: approvals shine but questions remain on competition 2 2018 Office of generic drugs (OGD) Annual Report