OGD updated its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) on Wednesday, giving us a look at some additional metrics for the month of August. For all the talk of Refuse-to-Receive (RTR) actions, OGD issued only seven (7) in August. Four (4) were for standard ANDAs and three (3) were for […]
On October 1, 2018, the FDA opened a portal (here) that permits firms to submit Controlled Correspondence (CCs) directly and electronically to the FDA. The process is further explained here, including how to register for use of the portal. This could help speed CCs to the Agency, but it is the problem with what happens […]
LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The […]
It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action. However, what can get overlooked during the investigation process is the importance of trending. This is a key component of root cause confirmation, assessing the appropriateness […]
Despite a slow start to FY 2018 due, in most part, to the elemental impurities issue, the Office of Generic Drugs (OGD) has broken the FY record for number of approvals. We are not quite sure by how much just yet because the numbers can continue to roll in over the next few days, but […]
The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format” (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents. There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix […]
This morning I read Zach Brennan’s post on RAPS, titled FDA Smashes Record for Most ANDA Complete Responses Letters (CRLs) in One Year (here ). In his piece, he wrote: But the gap between this year and years past – 2,515 complete responses have been issued so far in 2018 vs. 1,603 in FY 2017 […]
Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.” And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products. The FDA stated in its new release (here): This new plan includes several measures to help better communicate […]
The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA. The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify […]
