Menu
Your search for “Seguro automotriz Temple Terrace FL llama ahora al 888-430-8975 Carro seguro Presupuesto seguro automotor Costo seguro auto Seguro coche 1 mes Seguro para motos Mejor seguro para coche” returned the following results.
FDA Auto-Injector Citizen Petition Response Adds Greater Clarity to Drug/Device Combination Product Generic Drug “Sameness” Requirements – Clinical Usability is an Important Consideration
…Clinical usability or human factor studies may also be required, depending on the indication and the patient population, the nature of the auto-injector design, and differences from the auto-injector constituent…
FDA Approval of Generic IMITREX STATdose Sheds Some Light on Auto-Injector “Sameness” Issues – But What About Other Combination Products?
…auto-injector constituent part, [the Agency] must evaluate the auto-injector constituent part of the combination product for which ANDA approval is sought to ensure that its performance characteristics and critical design…
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)….
FDA Releases Draft Guidance on Enrichment Strategies for Clinical Trials
…support effectiveness and safety claims.” It also “defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies…
Coming Soon for Expanded Access Policies
…obtain information about the outcome. The potential for poor outcomes in the expanded access setting and the potential for those outcomes to adversely affect the approval process has been cited…
Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book Listing
…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August 2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
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…
Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution
…exclusive approval, as appropriate, for those additional subsets from the date of such additional marketing approval(s). Before obtaining such additional marketing approval(s), the sponsor in this instance would not need…
The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity
…to offer the qualifying product at a “reasonable price” (as defined in the bill) and to publicly disclose all pre-clinical and clinical trial data relating to the product, the award…
Upcoming WHO and CND Meetings Could Impact Scheduling of CBD and Cannabis
…Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plants and Resin; and Eight Additional Substances; Request for…
ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)
…petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm. And although it remains a viable route for many generic drug applicants to obtain approval of a…
FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?
…standard for surrogate endpoints to be utilized for purposes of every Accelerated Approval (i.e., be “reasonably likely to predict” ultimate clinical benefit). Moreover, in every Accelerated Approval, the clinical benefit…
‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules
…in comments from the National Association of Attorneys General. All of this is the long way to say that Congress’s concern about delays in the issuance of a final rule…
Massachusetts District Court Denies Class Certification Motion in NEURONTIN Litigation
…defendants allegedly used a national marketing scheme to promote a fraud. If true, they should not get off scot-free if there is a practical statistical way to address the difficult…