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 […]
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 […]
The 11th annual Workshop on Recent Issues in Bioanalysis (WRIB) has ended in sunny Hollywood, CA. The WRIB provides an opportunity for both industry and regulators to discuss challenges facing the bioanalytical community in the analysis of both small and large molecules. This year’s workshop had the largest turnout ever, with approximately 750 attendees from […]
Paul F. Vogel has announced his retirement as Chairman of the Board of Lachman Consultants, effective March 31, 2017. Paul plans to spend more time with family and his many personal interests, following a 44-year career that included 21 years at the U.S. Food and Drug Administration followed by 23 years at Lachman Consultants. Richard […]
It’s late, do you know where your data is? Are you really sure? Would you be able to assure a regulatory agency that you fully understand and control the flow of data from data generation through processing, reporting, data review, archive and retrieval? If the answer to all the above questions is yes, congratulations! Unfortunately, […]
Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews. Am I seeing this correctly? Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs […]
First of all, this is not a political blog. Second, I am certain that someone will still think it is. Third, in this case, I do not care as I am an ex-FDAer that truly believes in the Agency and wants to see it succeed. I was rooting for Scott’s nomination for many reasons, […]
In a Federal Register Notice published today, FDA announced that the direct final rule on “Use of Ozone Depleting Substances” published on October 26, 2016 is “excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’ this action confirms the effective date […]
A memo and its attachments was issued on February 6, 2017 to give various position classes, including pharmacist, consumer safety officers, microbiologists, chemists, medical officers, etc., which cover many of the FDA position classifications. Also, there is no freeze of the hiring of Commissioned Corps Officers of the United States Public Health Service. Hopefully, this […]
