The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday. August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017. These approvals are quite an accomplishment given the fact that the slowdown in […]
The GDUFA II reauthorization process involved a lot of agreements from the FDA. One of those agreements was for the Agency to publish a guidance on changes to drug substances that addressed the type of changes, their categories for submission (PAS, CBE, CBE-30, or annual report) and the necessary documentation that must be submitted to […]
I know that the flag was raised in victory when the first generic of EpiPen was approved. Not many people outside those familiar with the plight of complex generic products could understand how or why it took so long for a generic version of that product to make it through the approval process. This is […]
The Association of Accessible Medicines (AAM) meeting in Baltimore this week saw a number of FDA presentations. One that caught my attention was presented by Sarah Barkow, Ph.D., Acting Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing Quality in CDER. It had to do with data integrity. Dr. Barkow noted, “about 40% of […]
Historically, the Office of Generic Drugs (OGD) has classified major/minor amendments on the time necessary for review. Minor amendments required minimal review, while major amendments required extensive review. If there was an issue with a facility (e.g., cGMP), the old Deficiency Letters (DLs) and Complete Response Letters (CRLs) used to state that the firm should […]
According to our best calculations and current data on the FDA “All Approvals” page (here), it appears OGD has approved forty-seven ANDAs and tentatively approved eleven ANDAs in the month of August. These numbers are far below the record breaking ninety-six full and thirty tentative approvals seen in the month of July. This is not […]
As we know July was a record breaking month for approvals as reported here, but it was also a record shattering month for Complete Response Letters, beating the October 2017 previous total of 325 with a whopping 357 CRLs. This may be a little disturbing as the trend in FY 2018 is for an overall […]
While you are attending the AAM GRx + Biosims meeting September 5-7, 2018 at the Hilton Baltimore, please be sure to visit Lachman Consultant Services at booth 13/14 and drop your business card for a chance to win an iPad 9.7 and Apple pen! As they say, you’ve got to be in it to win […]
On September 5, 2018, at 1:30 PM, Lachman Consultant Services’ CEO and President and CEO will be moderating a panel on Data Integrity at the AAM GRx + Biosims meeting. Ms. Zipp will be joined by Derek Glover (Head of Global Quality Systems and Compliance, Mylan Pharmaceuticals Inc.), Sarah Barkow, Ph.D. (Lead Consumer Safety Officer, […]
I just searched through 643 hits on Regulations.gov for 505(j)(2)(C) petitions. Granted, all of those were not actually for ANDA suitability petitions under the citation listed above, but most were. The good news is that the industry still submits these petitions (an ANDA suitability petition requests a change from a reference listed drug in strength, […]
