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…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…
…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,…
…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…
…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…
…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…
…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…
…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…
…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…
…life, improved physical condition, or reduced pain. . . . [A] drug is unsafe . . . if its potential for inflicting death or physical injury is not offset by…
…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…
…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…
…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…
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…
…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…
…the fiscal year-over-fiscal year “potential pay-for-delay” deal numbers, you compare the “potential pay-for-delay” deals as a percentage of the overall final settlement agreements for each fiscal year, then there is…