Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018

FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018.  This is quite an ambitious agenda!  This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see if some of your interests will be met or augmented by some additional Agency guidance.

Never on Sunday!?

The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today.  And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur).  Anyway, I digress!  The reason I bring up “Never on Sunday” is, because, as I flip through the FDA’s All Approvals list,

Homeopathic Drugs- Home for the Holidays or Not?!

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 a result of the Agency’s evaluation,

FDA Provides Interesting Enforcement Information

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 in the slide below.

Final Guidance on Abuse-Deterrent Opioid Generic Drug Testing Arrives – High Burden of Proof!

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 has properties that are expected to (or have been shown through postmarketing studies or trials to) deter abuse,

Should an HBEL (Health Based Exposure Limit) be the Basis for Acceptance Values for Manufacturing Cleaning Validation?

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 Generation and use of Health-Based Exposure Limits” held on 20-21st June 2017 at the European Medicines Agency.

Don’t Disregard Your OOS Rate

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 by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results. 

Compounding Pharmacies Still in FDA’s Crosshairs

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 is certain that FDA is continuing to apply pressure on this industry with no letup in sight.

AAM Session on Bioequivalence Provides Food for Thought and Good Recommendations

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 the many new BE guidance recommendations,

Improving Health of the Least of Us for the Benefit of All of Us – A Guest Blog

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,