Menu
Your search for “Cotizacion de seguros para autos Sonoma CA llama ahora al 888-430-8975 Responsabilidad civil seguro automotor Del seguro contra robos de autos Aseguradora plan seguro Como funciona el seguro de automovil Seguros por meses de coches Seguros coche baratos” returned the following results.
Are the Stars Lining Up for FDA Civil Penalties?
By James P. Ellison – FDA’s November 12, 2008 Federal Register Notice of its Direct Final Rule to comply with the Federal Civil Penalties Inflation Adjustment Act, 28 U.S.C. §…
Supreme Court Rules that SEC and Potentially Other Agencies Cannot Impose Civil Penalties in Administrative Proceedings
…decades on the assumption that many disputes can be adjudicated by ALJs. According to a review of federal law she cited, by 1986 there already were more than 200 federal…
Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice Strategy
…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…
The Times They are A-Changing: The Baucus Plan – What Health Care Reform Could Look Like in the New Congress
…Exchange was created. Second, the Baucus Plan would reform Medicaid to create a mandatory national eligibility minimum of 100 percent of the Federal poverty level and also require states to help…
FDA Issues Five-Year Drug Safety Plan; Draft Plan Limited to So-Called “PDUFA IV Drug Safety Enhancement Resources”
…any temporal limitation) for which user fees revenues can be expended by adding the development and use of “improved adverse-event data-collection systems,” “improved analytical tools to assess potential safety problems,”…
Groups Challenge FDA’s PLAN B Approval
…PREA’s (and thus FFDCA’s) requirements. FDA’s PLAN B approval has been controversial. It seems unlikely, however, that the AAPS complaint -despite some novel arguments- will result in FDA withdrawing approval.…
FDA Will Approve Plan B Without a Prescription for 17-Year Olds
…Agency stated that the non-prescription use of Plan B presented novel issues, and that FDA was committed to “a careful and rigorous scientific process,” although an advisory panel convened by…
Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?
…of the BPCIA—seemed to have waned a bit in recent years, perhaps coinciding with an end to the Federal Trade Commission’s (“FTC’s”) annual reports on “Agreements Filed with the Federal…
HHS OIG Announces FY 2008 Work Plan; 9 New FDA Studies Identified, Including Clinical Trial Oversight and Off-Label Promotion
…must meet to justify disqualifying a clinical investigator from receiving investigational products for use in clinical trials. Financial Disclosure Requirements for Clinical Investigators – OIG will review the disclosure to…
For Whistleblowers, Complaining to the Government Pays: GlaxoSmithKline Pays $750 Million to Resolve Criminal and Civil Liability for Alleged cGMP Failures
…being aware of these errors, GSK continued to ship these products to market. The parallel civil case, U.S. ex rel. Cheryl Eckard v. GlaxoSmithKline, et al., was brought six years…
District Court Dismisses PLAN B Case Against FDA Based on Lack of Standing and Failure to Exhaust Administrative Remedies
…FDA’s August 24, 2006 approval of a supplemental NDA (“sNDA”) for Duramed’s emergency contraceptive PLAN B (levonorgestrel) Tablets, 0.75mg. FDA’s August 24, 2006 approval permitted Over-the-Counter (“OTC”) use of PLAN…
FDA Seeks Comments on Proposed List of Medical Device Accessories Suitable for Class I Classification
…on the final list. FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I…
CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program
…to several requirements and operational processes, and CMS will implement it in a similar manner. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and…
If at First You Don’t Succeed, Try, Try, Try Again: FDA Issues Plan to Increase Efficiency of 510(k) Third Party Review Program
…Reviews (the “Plan”). One element of the Plan includes the issuance of a draft guidance, “510(k) Third Party Review Program.”[1] With the issuance of this Plan and draft guidance, it…
FDA Releases Plan Intended to Improve the 510(k) Program; Plan Contains 25 Action Items to Implement During 2011
…The full action plan and remarks from CDRH Center Director Jeffrey Shuren, M.D., J.D. can be accessed here. Our brief summary of the plan is laid out below. Guidance Documents…