Definition Packaging Regulations Vaccine 
The Pharma Data
NOVEMBER 22, 2020
As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.
Agency IQ
NOVEMBER 3, 2023
Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. Postbiotic: “Preparation of inanimate micro-organisms and/or their components that confers a health benefit on the host,” according to the ISAPP definition.
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Agency IQ
NOVEMBER 3, 2023
A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices.
The Pharma Data
JANUARY 9, 2021
See “Reconciliation of Non-GAAP Measures” for a definition of the terms and reconciliation tables.). • Anthrax Vaccines. ACAM2000 ® , (Smallpox (Vaccinia) Vaccine, Live) vaccine deliveries are expected to continue under the terms of the Company’s existing contract with the U.S. .
Agency IQ
JULY 12, 2024
A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” Following this regulation, the EMA now coordinates shortage prevention, management and communication efforts among Member States.
Agency IQ
APRIL 8, 2024
FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).
Agency IQ
JANUARY 19, 2024
Though some biological products may be developed using PCCs, such as viral vaccines, these cultures are also commonly used for in vitro experiments that seek to mimic in vivo conditions as closely as possible (e.g., for renal function studies ). Secondly, their use minimizes both the risk and the impact of viral contamination.
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