Up in Smoke

Well, not really-but on April 12, 2016 (my birthday), the FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER) gave a presentation (here) entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  It is quite interesting to note that FDA has been actively involved in the regulatory assessment of cannabinoid products for quite some time. 

Terri Nataline and Fran Zipp Present at the 5th Annual Global Pharma Regulatory Summit

On April 25, Terri Nataline and Fran Zipp participated in a summit focusing on global strategies for Indian pharmaceutical companies, the Annual Global Pharma Regulatory Summit, in Mumbai, India. This summit brings together global regulators who shared their knowledge about complying with international regulatory guidelines for manufacturing and exporting pharmaceuticals. Terri Nataline, Principal Consultant, presented in 2 sessions dealing with US FDA specific requirements,

Fran Zipp Presents at the Generic International Summit

On April 21, President and CEO of Lachman Consultants Fran Zipp gave a presentation at the 6th Annual Generic International Summit (GIS) in Shanghai, China. Her talk, “Data Integrity and Quality Culture” was part of a session on “Consistency Evaluation and Formulation”. She discussed the history of Application Integrity Policy (AIP), recent trends in data integrity related enforcement actions in the US and ex-US,

What Happens Now?

It appears that if you wait long enough, things come full circle.  Take, for instance, claims that some artificial sweeteners cause cancer, or that coffee was bad for you, or that chocolate only made you fat. Well, that appears to be in the cards for the Black Box warning on the smoking cessation drugs Chantix and Zyban. 

FDA Proposed Labeling Rule – The Story Behind the Story

Most of the pharmaceutical industry has issued White Papers, blogged, sent letters to FDA, and lobbied their trade associations over the FDA’s Proposed Labeling Rule that would permit generic manufacturers to unilaterally add safety information to their approved labeling.  Even Congress is getting into the act in trying to derail the FDA’s proposal.  The Proposed Rule is in direct conflict with the statute and all regulatory advice the FDA has given since the passage of Hatch-Waxman. 

Data Integrity Guidance Issues – Sounds Like a Softer FDA Song

While the number of data integrity (DI) findings have increased over the last few years, as evidenced by citations in a number of Warning Letters, the FDA stance on DI seems to have mellowed since the generic drug scandal of the late 1980s.  The FDA guidance document (here)   walks firms through their responsibilities in assuring that cGMP requirements relative to assurance of the accuracy,

Bioequivalence Study Recommendations Published for 35 Products

In an ever-increasing effort, the Office of Generic Drugs (OGD) is keeping on top of this aspect of industry’s desire to obtain guidance on establishing bioequivalence for generic drug products. Today FDA published new bioequivalence (BE) guidance for 35 drug products and revised guidance for 8 previously issued recommendations.  The entire listing of the newly issued and revised guidance document can be seen here.

Do the FDA Commissioner’s Remarks Spell Trouble for Generic Opioids?

In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them.  He emphasized that there needs to be a multipronged approach that reaches practitioners,

ANDA Approval Numbers for March 2016 Are In!

FDA had the second highest monthly post-GDUFA number of full ANDA approvals at 63, and with 16 tentative approvals the total for approval actions for March 2016 hits 79.

The full ANDA approval picture is looking a bit rosier with the second highest month this FY and also the second highest number of full approvals post-GDUFA.

TEA Anyone?

The FDA has published a proposed rule regarding Time and Extent Applications (TEAs) that will establish timelines and metrics associated with their review.  Just to remind you, a TEA is now the preferred option to add a product to an over-the-counter (OTC) monograph for products that were initially marketed in the United States after the OTC review began in 1972 and for products with no US marketed experience.