By Ricardo Carvajal – FDA released data for its Total Diet Study (TDS) covering the period from 2006 to 2011. Under the TDS, FDA collects data on levels of pesticide residues, industrial chemicals, toxins, and nutrients present in foods to monitor changes in the levels of …
It’s July, and that means the American Bar Association (“ABA”) has initiated the annual process for selecting the top legal blogs (or “blawgs”) in the blogosphere. The 8th iteration of the list will be revelaed later this year when the ABA announces the “Blawg 100” …
By Kurt R. Karst – Earlier this week, and just a day after the second anniversary of the 2012 FDA Safety and Innovation Act that, among other things, includes the Generic Drug User Fee Amendments (“GDUFA” ), FDA announced the release of two draft guidance documents …
By Kurt R. Karst – Earlier this year we posted on two pending lawsuits brought by potential biosimilar applicants challenging the the so-called “patent dance” patent resolution provisions added to the PHS Act by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The BPCIA …
By Wes Siegner – Just in time for the windup to ad campaigns for the fall/winter cold/flu season, FDA has sent Zarbee’s, Inc. a Warning Letter alerting the company that its dietary supplement products are in fact illegal drugs, some prescription drugs, given the claims that the …
By Kurt R. Karst – The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, …
By Ricardo Carvajal – FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant …
By Jeffrey N. Wasserstein – On July 2, 2014, five U.S. Senators sent a letter to the head of the Office of Management and Budget (“OMB”) urging OMB to release a draft guidance proposed by the U.S. Food and Drug Administration (“FDA”) relating to the regulation …
By Karla L. Palmer – Yesterday FDA provided drug compounders some pre-Fourth of July fireworks by issuing a slew of “policy documents” as part of the Agency’s implementation of the Compounding Quality Act (“CQA”) (Title I of the Drug Quality and Security Act (“DQSA”)), which was …
By Douglas B. Farquhar – Drug compounders who are thinking about registering with FDA to become “outsourcing facilities” – and those 40 + that already have – will be interested in the details of FDA’s recent recognition that all of the rigid requirements for “current Good …
By John A. Gilbert, Jr. & Larry K. Houck – As expected, the Drug Enforcement Administration (“DEA”) published its final rule in the Federal Register today (79 Fed. Reg. 37,623 (July 2, 2014) placing tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol) into schedule IV of the federal Controlled Substances Act (“CSA”). …
By Kurt R. Karst – Ever since the FDC Act was amended in November 1997 by the the FDA Modernization Act (“FDAMA”) to add a new section creating a period of “pediatric exclusivity,” we’ve had more than a passing interest in the provision. In fact, it …
By Kurt R. Karst – It’s been quite a while since we last posted on the so-called “RLD (Reference Listed Drug) Theory of Liability.” It’s the theory put forward by plaintiffs’ attorneys in a lot of failure-to-warn generic drug product liability cases which posits that FDA’s …
