Manufacturers Food, Drug and Cosmetic Act

News & Analysis as of

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

A Symbolic Victory? FDA's Final Rule On Stand-Alone Symbols In Medical Device Labeling Raises Important Litigation Risk Questions

FDA this week released a final rule that will undoubtedly raise new litigation questions for medical device manufacturers in the context of product liability claims. The final rule, for the first time, permits medical device...more

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products

Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule. On May 10, 2016, the U.S. Food and...more

FDA Extends Regulatory Authority Over All Tobacco Products, Including E-Cigarettes, Cigars and Hookahs

The U.S. Food and Drug Administration (“FDA”) today issued historic final rules that extend the statutory definition of "tobacco products" to e-cigarettes, pipe tobacco, dissolvables, cigars, and “novel and future products.”...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

Weird "Science" = Preemption

Here at the DDL Blog, we write from time to time on food litigation. You might think it’s out of left field, and sometimes we even justify our food posts by pointing out that the “F” in FDCA stands for “Food.” But we need...more

Are Cosmetics Gaining Higher Congressional and FDA Scrutiny?

Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan...more

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

Pin the Blame on the Corporate Officer: Senators Introduce Hide No Harm Act

Three Senate Democrats recently introduced a bill that seeks to hold company executives of a product maker or seller criminally liable for knowingly "failing to inform and warn of serious dangers" associated with a product....more

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Ninth Circuit limits Medical Device Amendment preemption of post-PMA tort claims

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices....more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

IRS Releases Final Rule on Medical Device Tax

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

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