The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory. The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the […]
During the afternoon session at the first annual GRx+Biosims Meeting held in Baltimore, MD, from September 5-7, 2018, a panel discussion was held to deliberate over aspects that are important to consider when developing a complex generic drug product. The panel consisted of FDA as well as generic industry representatives. GDUFA II provides drug manufacturers […]
In a posting on FDA.gov yesterday, September 5, 2018, FDA Commission Scott Gottlieb, M.D., further reinforced his goals of an open and transparent FDA by publishing FDA’s internal policy on inspection site selections (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm). The Center for Drug Evaluation and Research (CDER) issued their internal policy Manual of Policies and Procedures (MAPP) 5014.1, Understanding CDER’s […]
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, […]
