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You Had Us At “Biosimilars,” FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain “Biological Drugs”
…for an approved drug product) to support approval” (italics in original). FDA’s petition response (like the Agency’s draft guidances) raises a host of unanswered questions. For example, what series of…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…for OTC MIRALAX for the relief of occasional constipation. After the approval of OTC MIRALAX, FDA removed all Orange Book references to NDA No. 020698 (prescription MIRALAX), and in April…
PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use Grounds
…other things, the PTO cites in its denial the Federal Circuit’s decision in Arnold P’ship v. Dudas, 362 F.3d 1338, 1341 (Fed. Cir. 2004), concerning a PTE denial for VICOPROFEN…
FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted
…course During the April 2025 Generic Drugs Forum (beginning at the 2:38 mark), FDA officials reasserted the August 1 deadline—but also hinted at flexibility in cases of product shortages or…
CMS Publishes Proposed Rewrite of Medicaid Drug Rebate Program Regulation; HP&M Issues Summary
…proposed regulation would: Require states to convert to an actual acquisition cost basis for Medicaid prescription drug payment Expand the MDRP to the U.S. territories Apply a statutory alternative rebate…
What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?
…with personal use importation. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) Section 5 of the May 12 EO states that…
A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called For
…generic version of a pre-1962 drug under the pre-Hatch-Waxman ANDA approval procedures, based on the 80,000 series application number). On December 28, 1998, FDA approved Mylan’s ANDA No. 040298 for…
USP Proposes Standards for Probiotic Food Ingredients
…FCC standards, proposes standards to be included as new FCC Appendix XV, titled “Microbial Food Cultures Including Probiotics.” The proposed standards provide a broad description of microbial food cultures (“MFCs”). …
FSIS Proposes to Further Expand the Types of Labels that Do Not Require Pre-Market Approval
…for approval sketches of their labels showing all required label features and any special claims that the establishments intend to make, e.g., quality claims, natural claims, and nutrient content claims. …
Betelgeuse, Betelgeuse, Betelgeuse! The ANDA “RLD Theory of Liability” Rears Its Ugly Head
…is withdrawn does not confer any additional or special responsibilities or obligations on an ANDA RLD sponsor. Several of the points MGP makes in its comments to FDA are reiterated…
FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett “Grandfather” Drug Petition
…of opium and a Schedule II controlled substance, “pose particular safety concerns because of their potential for addiction.” FDA illustrates this point by citing several examples of marketed unapproved Oxycodone…
USTR Embraces “TEAM” Approach in TPP Talks; Senators Back 12-Year Exclusivity for Biologics
…Asia-Pacific regional trade agreement being hammered out among the United States and eight other partners. The TPP would cover trade in goods and services and also includes a proposed chapter…
FTC Issues Long-Awaited Final Report on Authorized Generics; Report Examines Both the Short-Term Effects and Long-Term Impact on Competition and Drug Prices
…(e.g., data on Paragraph IV certification filings and 180-day exclusivity), says that the bottom line is that although “authorized generics have a substantial effect on the revenues of competing, generic…
Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing
…FDA’s confidence in the ability of generic manufacturers to perform ongoing pharmacovigilance duties – which makes sense, given their substantial scientific and financial resources, as well as the effort they…
Cosmetic Advertisement + Photoshop = Deceptive Advertising?
…body in the United States, reviewed an advertisement for one of Maybelline’s “Eraser” line of cosmetics and came to a slightly different conclusion. NAD Case #5241, Maybelline New York Inc.,…