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FDA Issues Final Orphan Drug Regulations
…additional designation requests for the drug to cover these additional indication(s) or use(s) – because they would fall within the original designation. Additional orphan-drug exclusivity may attach upon approval of…
New Draft Guidance Elaborates on the Definition of “Applicable Drug Clinical Trial” under FDAAA Title VIII; Most Bioequivalence Studies are Exempt from Registration
…particular clinical trial is an “applicable drug clinical trial” under Title VIII of PL 110‐85 (section 402(j)(1)(A)(iii) of the PHS Act). Although Phase 1 clinical investigations are generally designed to…
Department of Defense Issues Proposed Rule for the TRICARE Retail Pharmacy Refund Program
…the difference between the Federal Ceiling Price and either (a) the most recent annual non-Federal average manufacturer price (“Non-FAMP”) reported to the VA, or (b), at the manufacturer’s option, “direct…
Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!
…right? And, in any case, having delayed pulling together this post, we now have the benefit of some rather interesting statistics and information from FDA’s Fiscal Year 2020 Justification of…
It Feels Like the First Time: FDA’s First Competitive Generic Therapy Approval
…Contrast this with Paragraph IV 180-day exclusivity, which blocks the approval of a subsequent applicant after a first applicant has submitted an application containing a Paragraph IV certification thereby preserving…
ACI’s 13th Annual Paragraph IV Disputes Conference
…Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around the corner. That’s right, ACI will be holding its 13th annual “Paragraph IV Disputes” conference…
FDA’s Summer Plans May Include LDT Rulemaking
…vulnerable to legal challenge on procedural grounds. See, e.g., ACLA White Paper on LDTs here. Rulemaking avoids the twin problems of dependency on action by Congress and the legal weakness…
DDMAC Issues Two Untitled Letters Focusing on Comparative Claims and the Need for Substantial Evidence; A Momentary Departure From Past Practice or a Sign of Things to Come?
…the other regarding a detail aid for Schering Corporation’s NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg. FLONASE and NASONEX are approved for seasonal allergic and perennial allergic rhinitis in…
District Court Takes Another Logical Step to Expand the Safe Harbor
…obtained and the trial concluded. Further, international standards for medical research require trial sponsors to allow participants to access the studied treatment even after the trial’s conclusion. The Court here…
Swanson Health Products Files Citizen Petition Requesting FDA Action to Block Application of Proposition 65 to Foods and Dietary Supplements
…as applied, conflicts irreconcilably” with the Federal Food, Drug and Cosmetic Act (“FDC Act”), and FDA regulations. Proposition 65 requires all products sold in California containing any chemical “known to…
Group Challenges FDA Enforcement Action on Marketed Unapproved Hydrocodone Drug Products; Claims GRAS/E Status Exists for Liquid Cough/Cold Hydrocodone Drug Products
…final DESI determination classified a drug as effective for its labeled indication, then “FDA still requires approved applications for continued marketing of the drug and all drugs [Identical, Related, or…
FDA Issues Another “Final” Rule on Antiseptics; Defers Action on Three Active Ingredients for Use in Consumer Antiseptic Rubs
…alcohol and povidone iodine), and, now, the consumer antiseptic rubs (ethyl alcohol, benzalkonium chloride and isopropyl alcohol). FDA has not set a specific deadline for final action on these ingredients…
FDA Will Meet to Address Possible Behind-The-Counter Drug Availability
…the contraceptive drug PLAN B (levonorgestrel) Tablets. Moreover, FDA has previously considered and declined to create BTC drug status. Specifically, in 2003, Pharmacists Planning Service, Inc., a non-profit organization that…
FDA Publishes Final Rule on Dietary Supplement cGMPs & Issues Interim Final Rule on Dietary Ingredient Identity Testing
…rule allows testing of a “subset of finished dietary supplement batches [identified] through a sound statistical sampling plan” rather than testing of all finished batches. Because validated testing methods for…
Risk Management: FDA Announces New Risk Communication Advisory Committee & AHRQ Issues User’s Guide to Patient Registries
…life, improved physical condition, or reduced pain. . . . [A] drug is unsafe . . . if its potential for inflicting death or physical injury is not offset by…