The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

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Agency IQ

JUNE 2, 2023

However, only licensed blood establishments would be required to submit PMI to FDA for approval.” Some exemptions: Vaccine manufacturers are likely to benefit from the FDA’s proposed rule. It’s worth noting that FDA’s definition of approval includes efficacy supplements, and not just the date of first approval.

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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. . . . 1981) (applying Virginia law), both of which involved vaccines. Lederle Laboratories , 819 F.2d

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Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

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