April 2016

29
Apr

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 […]

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27
Apr

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 […]

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27
Apr

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 […]

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25
Apr

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 […]

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20
Apr
Draft Guidance on Changes to ANDA Labeling Where the RLD Has Been Removed from the Market Image

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 […]

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17
Apr

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 […]

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