We were pretty close on our estimates from a day ago (see previous post here). The good thing to take away from yesterday’s post is we now know that the “All Approvals” report (here) and the OGD report of approvals and tentative approvals are now in sync. In April, OGD approved 56 full new ANDAs […]
Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month. In addition, the FDA Approved Drug Products daily listing (here) can […]
James Davidson, Ph.D., Vice President, Science and Technology, will be moderating a session at the Food and Drug Law Institute Annual Meeting in Washington, D.C. The session, “Responding to and Remediating Data Integrity Issues in a 483 or Warning Letter’, will take place on Friday, May 5 at 12:30 PM in the Ronald Reagan Building […]
The Office of Generic Drugs (ODG) saw the largest number of changes being effected (CBE) supplements (618) as well the largest number of prior approval supplements (PAS) (57) so far, this fiscal year. While these numbers did not break any previous records (678 CBEs in September 2016 and 71 PAS in August 2016) they certainly […]
With the recent publication of the GMP Inspection trends for 2016 from the MHRA (here) and the FDA (here), companies involved with the observations might want to reconsider their internal audit processes. If you evaluate the examples of the issues observed, you would question why internal audit programs do not catch many of the issues […]
The FDA announced today that it issued Warning Letters to 14 companies for selling unapproved cancer treatments ranging from thermal devices to creams, ointments, syrups, teas, and various pills. Life is too short to have charlatans trying to steal precious chances for life from cancer patients. While I am glad that the FDA has acted, […]
The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation can be found here. In comparison to 2015, the MHRA increased […]
The FDA has just updated previous warnings from July 1 and September 21, 2015 (here and here) for use of these two products in children. The new language contains stronger warnings in the form of contraindications for the use of the product in children under the age of 12 and in certain circumstances outlined below […]
When we look at the number of ANDAs coming into the Office of Generic Drugs (OGD), one might stop to say, how can this be? There has been so much M&A activity in the generic market, some would think that this might be a reason to see the number of submissions decrease or at least […]
Following the lead of many of the world’s pharmaceutical regulatory agencies, on April 6, 2017, the Australian Therapeutic Goods Administration (TGA) released a Data Management and Data Integrity (DMDI) policy statement. TGA states that the policy “serves to provide some clarification regarding the TGA’s official position regarding DMDI practices for industry,” but at the same […]
