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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…
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…
Potential Major Changes in Updated Draft Pre-Sub Guidance
…a normal Pre-Submission, three-to-four questions could relate to a clinical study plan alone without addressing other important questions such as regulatory strategy. The guidance does not state what, if anything,…
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…
President Bush Proposes FY2009 FDA Budget; Follow-On Biologics and New User Fee Legislation on Tap for 2008, as Well as Plans to Resurrect FDAAA DTC TV Ad User Fee Program
…to expedite the approval of Abbreviated New Animal Drug Applications. Sponsors of innovator drug products currently pay user fees under the Animal Drug User Fee Act; Reinspection user fees to…
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…
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 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…
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…
FDA Issues Draft Guidance Clarifying Clinical Study Investigator Responsibilities
…medical problems arising during participation in the trial, reasonable access to medical care, and attention to protocol violations that can expose study subject to unreasonable risks. By Noelle C. Sitthikul…
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…
D.C. Court of Appeals Sidesteps Issue of FDA Classification of Dental Amalgam Devices
…Congress might also hold hearings on the health risks associated with EAADM, and Representatives Dan Burton (R-IN) and Diane Watson (D-CA) reportedly plan to reintroduce legislation that would phase-out dental…
U.S. ex rel. James Marchese v. Cell Therapeutics, Inc.
…Intervention, CTI allegedly implemented a plan to convince physicians and Medicare carriers that various off-label uses of TRISENOX were medically accepted and eligible for Medicare reimbursement. Many oncologists rely on…
Deficit Reduction Act of 2005 False Claims Act Education Requirements Are Not Applicable to Pharmaceutical Manufacturers
The Deficit Reduction Act of 2005 (“DRA”) provided that any entity that receives or makes annual payments under a Medicaid State plan of at least $5,000,000 must, as a condition…
Sentencing Hearings for Synthes Executives Suggest that Government May Try to Prove Fraud In Connection with Park Cases
…the other that although the “Court well understands and respects historical sentencing practices for responsible corporate officers under the Park doctrine . . . This case stands alone.” This scenario…