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FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations

FDA Law Blog

Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. This means that manufacturers of diagnostic x-ray systems no longer need to submit an accession number when importing products.

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

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Is ASCA worth it? FDA’s Accreditation Scheme for Conformity Assessment

FDA Law Blog

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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Prefilled Syringes: Delivering Convenience and Precision in Every Dose

Roots Analysis

Further, prefilled syringes are being manufactured in different capacities, based on the requirements of stakeholder / end users in this domain. However, these syringes are associated with certain limitations, such as fragile nature, leaching of extractables, high manufacturing cost and heavy weight.

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INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

The Pharma Data

Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA). It will be funded by the U.S. About INO-4800.

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Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

XTalks

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. In addition, the cascades can also contain beta emissions.

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AZD1222 US Phase III primary analysis confirms safety and efficacy

The Pharma Data

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

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