The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. 5 Currently there is no cure or treatment for TBE, only management of symptoms.

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Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. The man was in Hong Kong for kidney treatment. A startup that makes such a spray has gained an EPA license to sell its product to customers in the consumer, commercial, and healthcare sectors.

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Virus Hospitals Production Regulations 75

New Drug Approvals

JULY 10, 2023

g/mol BASE Vazegepant BMS-742413 BHV-3500 FDA APPR 3/9/2023 Zavzpret N -[(2 R )-3-(7-methyl-1 H -indazol-5-yl)-1-[4-(1-methylpiperidin-4-yl)piperazin-1-yl]-1-oxopropan-2-yl]-4-(2-oxo-1 H -quinolin-3-yl)piperidine-1-carboxamide ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. 1] It is sold by Pfizer. [1]

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Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. Amendments to TSCA in 2016 included several new provisions concerning the assertion and Agency review and treatment of CBI claims.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. 2002); Tracker Marine, L.P. Ogle , 108 S.W.3d 3d 349, 358 (Tex.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

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Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 2003), aff’d , 810 N.Y.S.2d Another recent and thorough treatment of this subject is found in Robinson v. 2d 397 (6th Cir.

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