Those homeopathic drug products for which no determination that the product is a new drug may be marketed under the Federal Food Drug and Cosmetic Act. However, given the current burgeoning homeopathic market, the FDA held a public hearing on March 27, 2015 to seek comments on its current regulatory framework for such products. “As […]
FDA posted Donald Ashley’s, Director of the Office of Compliance (OC), presentation (here) at the FDLI Enforcement, Litigation, and Compliance Conference presented December 6, 2017. Mr. Ashley provided some interesting enforcement information, some of which is presented here. The FDA’s Biomedical Monitoring (BIMO) program warning letters issued over the last 4 fiscal years is captured […]
FDA published its final guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (here) as perhaps a Thanksgiving present to the generic drug industry. The theme throughout the document is “[i]f the summary in section 9.2 [of the RLD labeling] indicates that FDA has concluded that the product […]
Well, here we are, just before Thanksgiving again. It seems like just last week we were getting ready for last year’s shindig. We certainly have a lot to be thankful for this year and on top of the list is a clean bill of health after a horrible 2016 for my family. Second is the […]
The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the […]
As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR). The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated […]
From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations. It […]
The Path to Bioequivalence – Great Progress – Great Opportunities, was presented by Charlie DiLiberti, President, Montclair Bioequivalence Services LLC, at this week’s Association for Accessible Medicines (AAM) meeting. Charlie pointed out the great progress FDA has made in developing new bioequivalence techniques or alternate methods through the GDUFA regulatory science initiative. He pointed to […]
My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network. Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends, […]
There has been a ton of news in the pharmaceutical world this week so I thought I would diverge from my usual posts to provide some brief sound bites of things that caught my interest and will hopefully catch yours. First off, remember the New England Compounding Center (NECC) and the meningitis outbreak of 2012? […]
