So you think you can always get a Q1/Q2 (qualitative and quantitative sameness) determination from the Office of Generic Drugs (OGD) through a Controlled Correspondence? Well, think again. Well, getting this information from FDA may be easier said than done.
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 […]
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 […]
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 […]
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 […]
In an unusual 12-0 vote, an FDA advisory panel recommended that the acne treatment adapalene gel 0.1% be switched to Over-the-Counter (OTC) use. If the FDA concurs, this will be another FDA approved product to join a number of OTC monograph products in the OTC market to treat acne.
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 […]
Lachman Consultants was the Business Exposition Sponsor at the Generic Pharmaceutical Association Annual Meeting in Orlando, held February 22-24, 2016. If we didn’t see you there, we hope to see you at our booth there next year!
When reason does not win the day, use money! And that is just what Congress appears to be doing by keeping FDA from spending any appropriated funds on their controversial labeling rule that would permit generic manufacturers to revise their labeling to include new warnings. Our friends at RAPS had a nice article on this […]
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 […]
