On May 8, 2017, the US FDA’s Center for Radiological Health announced that it will be establishing a new digital health unit under the Office of the Center Director. This is just the latest step the Agency is taking to try to keep pace with the quickly evolving and rapidly growing digital medical device industry.
With Scott Gottlieb, M.D., winning confirmation to head the FDA yesterday, the Agency is ready to move forward to the beat of a different drummer. It will be an interesting ride and we will watch it along the way. It also looks like the User Fee legislation may make its way to law, as it looks like the last hurdles have been cleared.
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,
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 time noting that,
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 all over the world representing large brand pharmaceutical companies,
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 negotiated for reauthorization and at the 11th hour,
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 of February 23,
Well, not naming any names- I really won’t come out and say who my pick would be, but, depending on the administration’s pick, this is a pretty crucial decision for the Agency. Here are some of the attributes I think would be important for the position:
- A knowledge of the FDA review and approval process
- A strong medical background
- A person that believes that science should rule the day
- Someone who is above the political fray
- A person that has both compassion and common sense
- Someone with an understanding of how the drug industry operated
Which of these attributes do I think is most important?
FDA published an updated Manual of Policy and Procedure (MaPP), 5310.7 after a 10-year first edition and this one (in my opinion) really clears up one of the age-old questions – can I cite a foreign compendia as the basis for establishing a specification or test method in my application? The answer is a resounding YES!if the method is as good as or better than the USP/NF provisions in a Monograph or in the General Chapters.
Donald Trump signed an Executive Order freezing government hiring, except for the military, national security, or public safety personnel, and issued a memorandum placing a moratorium on any new regulations or Guidance. In addition, it is reported that the memorandum noted that if new regulations have been sent to the Federal Register, but yet unpublished,
For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions?
- Do you know the Federal and State laws you are required to follow?
- Do you have the right enabling documentation (procedures, policies,
While we usually cover drug- and device-related topics in this blog, something came swimming our way on an unrelated topic that I thought might pique your interest. I always thought that eating fish over red meat was a healthy choice. Well, that is still true, as long as you don’t eat too much. In a Federal Register (FR) notice (here) issued today,
In another generic drug Guidance issued in the beginning of the year, OGD Guidance tsunami, FDA has provided advice on how to decide what might be necessary to gain approval of an ANDA, where there is a drug-device patient interface. FDA notes throughout the Guidance that each ANDA will be evaluated on a case-by-case basis and the deciding factor will be that (as first explained in an old petition response to King Pharmaceuticals) “[i]n general,