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…the detailers’ incentive to visit; (3) preserve the integrity of the doctor-patient relationship by assuaging patient fears that their physicians are being unduly influenced by the drug companies; and (4)…
…be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds of companies for promotion of approved products for unapproved uses, commonly known as “off-label promotion.” …
…suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” Justice Ginsberg admonished the majority’s decision as contrary to the “MDA’s central purpose: to protect consumer safety.”…
…of the guides. Kaplan is a physician engaged in the business of providing medical services in exchange for payment: a commercial actor in a commercial setting, using a commercial product. …
…should be given its meaning in common parlance within the statutory context: In the world of pharmacology, a pharmacist engages in the act of dispensing when she “fill[s] a medical…
…court said. The court further affirmed the district court’s dismissal of plaintiff’s allegations about false statements to doctors caused the doctors to falsely certify the devices as “reasonable and necessary”…
…controlled substances. See, e.g., Kimberly Maloney, N.P., 76 Fed. Reg. 60922, 60922-23 (Sept. 30, 2011) (granting application of physician with felony conviction for obtaining controlled substance by means of forged…
…honors in chemistry) from Barnard College, Columbia University, and a Doctor of Medicine from the College of Physicians and Surgeons, Columbia University. She completed her residency and a fellowship in…
…risk of experimental drugs cannot draw support from the doctrine of self-defense.” The court also commented, citing, among other Supreme Court cases, the decision in United States v. Rutherford, that:…
…“fundamental right” protected under the Due Process Clause of the U.S. Constitution. WLF requests the Supreme Court’s consideration of the following question: Whether the Due Process Clause protects the right…
…(Gerber). The claims provided in FDA’s letter are: Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy,…
…ANDA #77-355 for a generic version of PEPCID COMPLETE (famotidine, 10mg; calcium carbonate, 800mg; magnesium hydroxide, 165 mg) Chewable Tablets, Perrigo was a “first applicant” based on the company’s Paragraph…
…(Appendix 7) making it easier to locate. FSIS invites comments. The comment period is open for 60 days. Meanwhile, FSIS advises companies to use the updated guidance when determining whether…
…that Solvay and generic companies violated various federal antitrust laws when they agreed to dismiss patent infringement litigation in exchange for a profit-sharing arrangement and provided the generic competitors would…
…meeting, register or email GenericDrugPolicy@fda.hhs.gov on or before July 7, 2020. FDA will also accept public comments through August 20, 2020 to Docket Number FDA-2020-N-1459. These types of meetings are…