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 […]
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 […]
In the “you learn something new every day” category, I got schooled by my good friend Lisa Parks from AAM this morning. After she read a quote from me pleading ignorance as to why there were so many ANDAs submitted in March, she cleared it up. It appears that March is the end of India’s […]
Today, FDA announced the current data they are collecting from which the “Program Fee” will ultimately be calculated for the three tiers of approved application holders. And while it is really not much of a surprise, based on some back of the envelope calculations we have done in the past, it may be a bit […]
We are pleased to announce that Jean Poulos has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective April 10, 2017. Ms. Poulos is a seasoned Regulatory professional with more than 25 years of combined quality assurance, quality control, regulatory affairs and compliance enforcement experience in the pharmaceutical / biotechnology […]
According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report […]
