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Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book Listing
…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August 2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
FDA Seeks Comments on Proposed List of Medical Device Accessories Suitable for Class I Classification
…accessory types are: (1) gastroenterology-urology accessories to a biopsy instrument; (2) penile implant surgical accessories; (3) ureteral stent accessories; (4) biliary stent, drain, and dilator accessories; (5) suprapubic catheter accessories;…
Budget Act Increases Brand Drug Companies’ Discounts Under Government Programs
…drug to the degree of the original drug’s price increases, in order to prevent manufacturers from avoiding price increase penalties by making small changes in a line extension. However, the…
The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity
…than bioavailabilty 68 studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, and the supplement shows a significant clinical benefit over…
Upcoming WHO and CND Meetings Could Impact Scheduling of CBD and Cannabis
…Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plants and Resin; and Eight Additional Substances; Request for…
When FDA Makes You An Offer You Can’t Refuse
…we cannot appeal her drug’s approval.) This isn’t to say that CDER as a whole has adopted this approach. CDER in fact recognizes that “[s]ince essential labeling discussions by necessity…
FDA Continues to Defy Congress on MDR Reporting (A Decade and Counting)
…processes for submission of electronic MDRs (eMDRs) to FDA, in accordance with the Medical Device Reporting: Electronic Submissions Requirements Final Rule (eMDR Final Rule) published in the Federal Register of…
Pitfalls of the Notification Pathway – “I’m Sciencing as Fast as I Can”
…Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff” Issued on May 11, 2020 (the “FDA Testing Policy”). FDA does not intend to object to a commercial manufacturer’s development and…
FDAAA § 912 – A Fundamental Shift in the Dividing Line Between Foods and Drugs
In a previous post we opined that § 912 of the FDA Amendments Act (“FDAAA”) could represent a fundamental shift in the dividing line between foods and drugs. For our…
Please Pass the Prune Juice: Must FTC Toe FDA’s Line on Health Claims?
…burden is on the government to prove (with empirical evidence) that no claim qualification will eliminate the allegedly misleading aspects of the claim. The petition raises questions concerning the constitutionality…
‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules
…a deadline (which is often missed). What makes this relatively unusual is that FDA, in the last round of user fee legislation, already directed FDA to do the very same…
Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice Strategy
…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…
Public Service Announcement: Don’t Trust FDA Impersonators . . .
By Jeffrey N. Wasserstein – First, it was the son of the former Nigerian dictator who wanted my bank account information (I’m still waiting for the bank transfer, by the…
The Perils of Being a Store Clerk in an FDA-Regulated World
…States Supreme Court in 1975, there has been substantial debate about the level of responsibility at a corporation that should subject an individual to a criminal prosecution. The government’s position…