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.
Del Monte Fresh Sues FDA to Invalidate Cantaloupe Import Alert
By Ricardo Carvajal – Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. (“PAO”), a…
Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities
…HHS also claims to be continuing to study the Trump era Most Favored Nation model, an international reference pricing demonstration model for select Medicare Part B drugs, although it was…
HHS Issues Import Safety Report; FDA Simultaneously Announces Food Safety Protection Plan
…Import Safety (“Import Action Plan”). HHS simultaneously announced an FDA Food Protection Plan (“Food Plan”). Although the Food Plan is presented as part of the broader Import Action Plan, FDA’s…
New York District Court Rebukes FDA Over PLAN B OTC Switch Approval Decision; Vacates FDA Citizen Petition Decision and Remands to FDA
…the Agency’s August 24, 2006 approval of a supplemental NDA (“sNDA”) for Barr Pharmaceuticals, Inc.’s emergency contraceptive PLAN B (levonorgestrel) Tablets, 0.75mg and denial of a citizen petition requesting FDA…
CDRH Issues Plan of Action Based on Booz Allen Hamilton’s MDUFA II/III Evaluation Priority Recommendations
…a comprehensive outside assessment of the medical device review process. The assessment was performed by Booz Allen Hamilton (“Booz Allen”). On December 11, 2013, Booz Allen released its initial report…
FDA Finalizes Postmarket Device Surveillance Guidance
…in the draft guidance, the final guidance states that the following additional information may be posted on the 522 webpage: General surveillance plan parameters: Design description, data source, comparison group,…
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
…three years of marketing exclusivity on the basis of actual use studies Teva conducted in women age 15 and 16 that FDA found essential to its approval. The approval does…
OIG Issues Advisory Opinion on Manufacturer-Subsidized Patient Reminder Program
…expanded vaccine that treats all of the bacterial strains covered by the original vaccine plus additional ones. Like the original, the expanded vaccine is the only FDA-approved pneumococcal conjugate vaccine…
First Constitutional Challenge to FDA’s Civil Money Penalty Authority
…non-mutual collateral estoppel does not prevent the federal government from re-litigating an issue that it has lost, especially at the district court level. In sum, this case raises some interesting…
CPSC Imposes Largest-Ever Failure to Report Civil Penalty against Baja Inc.
…alleged failure to report defects involving 11 models of go-carts and minibikes. According to the CPSC, Baja sold the go-carts and minibikes at issue from November 2004 to June 2010. …
“Responding to America’s Prescription Drug Abuse Crisis”: Administration’s New Action Plan Includes Changes to the CSA
…controversial. The Plan also calls on those states that have not implemented Prescription Drug Monitoring Programs (“PDMPs”) to do so. Currently 35 states have such plans. In addition, the Plan…
FDA Issues Proposed Rule and Strategic Plan to Address Drug Shortages
…comments analyzing the viability of a partner program, and the existence of a potential model in the Biomedical Advanced Research and Development Authority (“BARDA”) partner program. FDA also requested public…
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…to the controversial social and ethical implications of the drug’s availability, what was already an interesting case study in administrative law has become a 14-year saga of court battles, prescription-to-OTC…
California Court Rules that Bayer AG, et al. Did Not Violate State Antitrust Law in CIPRO Reverse Payment Case
…(cirprofloxacin). The decision follows in the footsteps of an October 2008 decision by the U.S. Court of Appeals for the Federal Circuit also concerning CIPRO reverse payments. The California case,…
FDA to Complete “Unfinished Business” of Device Classification & Call for PMAs
…10. 21 CFR 870.5200 External cardiac compressor. 11. 21 CFR 870.5225 External counter-pulsating device. 12. 21 CFR 870.5310 Automated external defibrillator. 13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form)….