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.
GAO Report Confirms the Obvious: Food Safety Has Been Driving the Bus at FDA’s FVM Program
…all of the FVM Program’s strategic objectives. In addition, GAO notes that the Strategic Plan as yet lacks an implementation plan that would lay out “specific actions, priorities, and milestones”…
CMS Proposes to Require WAC Disclosure in TV Ads for Rx Drugs
…is relatively straightforward. Any advertisement on TV (including broadcast, cable, streaming, or satellite) for a prescription drug or biological would have to contain the following statement: The list price for…
FDA’s Pre-Cert Program Enters its Testing Phase
…here, here, and here). In January of this year, FDA released version 1.0 of Developing a Software Precertification Program: A Working Model (Working Model) and an accompanying Software Precertification Program:…
Florida Proposes Plan to Import Drugs from Canada
…Care Administration (AHCA) to establish a Canadian Prescription Drug Importation Program and an International Prescription Drug Importation Program. Florida Governor Ron DeSantis signed the bill into law on June 12,…
Let’s Play a Game: What’s Missing from FDA’s Recent Approval Letter for Generic COPAXONE 40 mg/mL?
…example, FDA may conclude the paragraph with “You have also notified the Agency that the cases have been dismissed,” or with “this litigation is ongoing,” or with “Although these litigations…
A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification May Be More Than a Regulatory Violation
…civil allegations related to the same conduct under the False Claims Act. In light of the above approach to civil and criminal matters, companies now need to consider not only…
DOJ Files Criminal Case Against Vascular Solutions, Inc. for Off-Label Device Promotion
…forum shopping starkly contrasts with “the old days” when FDA criminal cases were almost always brought in the company’s principal place of business. This trend is troubling for companies because…
FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates
…“3-month pancreatic safety study in a diabetic rodent model treated with sitagliptin.” FDA documented the agreement in approval letters (here and here) with the following timetable: Final Protocol Submission: June…
Second Bill to Curb Underage Dextromethorphan Abuse Introduced in House
…the sale of dextromethorphan to individuals under 18 years old. Senator Robert Casey (D-Pennsylvania) introduced a companion bill, S. 644, the Preventing Abuse of Cough Treatment Acts of 2013, (also…
Allergan Settles with DOJ Related to the Sales and Marketing of BOTOX
…no criminal or civil charges were brought against individuals in this case. Notably, the Allergan press release mentions that the Government required Allergan to dismiss its First Amendment case, in…
Pfizer Reaches Record Settlement with Feds; Yes, That Is $2.3 Billion with a ‘B’
…Second, on the civil side, Pfizer has agreed to pay $1 billion in civil settlements of cases which were brought under the federal False Claims Act (“FCA”) by whistleblowers (called…
David C. Vladeck to Head the FTC’s Bureau of Consumer Protection
…University Law Center, teaching federal courts, government processes, civil procedure, and First Amendment litigation. He co-directed the Center’s Institute for Public Representation, a clinical law program for civil rights, civil…
Revised Legislation Introduced by Senators Kohl and Grassley Targets Industry Gifts to Physicians: Requires Reporting if Amount Per Year Exceeds $100; Includes Preemption Language; Does Not Exempt Small Companies
…civil monetary penalty of $10,000 to $100,000 for each offense, with up to $1 million in civil monetary penalties per annual report. Delayed Reporting for Payments Under Product Development Agreements…
I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)
…have also noticed a renewed emphasis on requirements related to remedial compliance programs in these civil settlements, often including a Memorandum of Agreement (MOA) with DEA and in some cases…
FDA Cracks Down on ClinicalTrials.gov Reporting Failures
…study site locations, and results. The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other…