Menu
Your search for “Cotizador de seguros para autos Auburndale FL llama ahora al 888-430-8975 Cotizacion on line de seguros automotor Precios seguros de autos contra terceros Valor de seguro de auto Que seguro es mejor para mi auto Cuales son los mejores seguros para autos Calcular seguro de coche barato” returned the following results.
PMA Panel Votes: More Than Meets the Eye
…votes and approval, but other variables changed over time, e.g., FDA’s user fee commitment. Even so, our research suggests that conventional wisdom sometimes needs a good dose of empirical scrutiny….
Just the Stats, Ma’am: FDA Increases Inspections in Foreign Countries, Resulting in a Higher Rate of Enforcement Actions than Imposed on U.S. Facilities
…dropped to 981 in fiscal year 2017, and rose slightly to 991 in the last fiscal year. (The total for fiscal year 2019 is incomplete, since that fiscal year doesn’t…
When FDA and the Practice of (Tele)Medicine Collide
…of the packages as “Personal Supply of Rx Medicines.” Notwithstanding this apparently accurate description, the complaint alleges that FDA, through U.S. Customs and Border Patrol and the U.S. Postal Service,…
FDA Finalizes Guidance on Process to Request Review of CFG Denial
…provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) to establish specific procedural rights and appeal options for device companies faced with a CFG denial. The following year, FDA…
Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)?
…of otherwise approved products) that may be effective medical countermeasures to combat a pandemic. FDA also has additional authorities, e.g., to waive expiration dating and Good Manufacturing Practice (GMP) requirements….
HP&M’s Food, Beverage & Supplement Wrap Up: December 2020
…uses or therapeutic uses, but not both – until this month, when FDA announced just such an approval of an alteration in a line of domestic pigs. See Ricardo’s post…
FDA Works Around the Clock, Provides More Detailed Guidance on the Conduct of Clinical Trials Amidst the COVID-19 Pandemic
…Ability to conduct assessments (in-person at site or alternative site or virtually) Availability of clinical trial supplies and continued operation of vendors, especially related to the investigational product (and whether…
GAO Analysis Says FDA is Meeting PDUFA Commitments
…impact goal dates. The Report explains that goal dates are directly related to four key features of NDAs: whether the NDA receives priority review designation; whether the NDA involves an…
Donald Trump Issues Executive Orders to Control Prescription Drug Prices
…drug payment rates under Medicare Part B to be based on an international pricing index derived from prices in 14 foreign countries. To date, the ANPRM has not reached the…
D.C. Circuit Reverses Lower Court, Clearing the Way for CMS Cuts in Drug Payment to 340B Hospitals
…6% to ASP minus 22.5%) would bring payment rates in line with actual drug acquisition costs under the 340B program. The court rejected the hospitals’ argument that, under Clause (II),…
Operation Warp Speed and the Standard for Review of the COVID-19 Vaccines
…would need to be widely disseminated in clinical trials, including with sufficient representation of racial and ethnic minorities, older adults, and individuals with medical comorbidities. Finally, the article states that…
CDRH Issues Draft Guidance Regarding Patient Reported Outcomes
…PROs in regulatory decision making, including through publication of PRO case studies and a PRO Compendium outlining instances in which PROs were used in clinical studies in fiscal years 2014…
Discount “Stacking” in Medicaid Rebate Best Price Addressed by Federal District Court
On November 5, the Maryland Federal District Court dismissed a Federal False Claims Act qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug…
OIG Fires Another Warning Shot at Drug and Device Companies’ In-Person Speaker Programs
…account the volume or value of past business generated or potential future business generated by the HCPs. The OIG acknowledges in the Fraud Alert that many in-person activities have been…
Festivus for the Rest of Us: How Competitors Can Air Grievances with the New Administration
A new administration always brings with it the excitement of new political appointees, briefing books and never-ending speculation about forthcoming changes in the direction of various agencies. It also brings…