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Health Care Week In Review: CMS Releases Guidance on Medicare Prescription Payment Plan and House Holds a Hearing on 19 Health Care Bills | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and...

United-states , American , America , Peter-marks , Andy-shih , George-reed-grimes , Corey-feist , Randy-strozyk , Phillip-swagel , Michelle-whitten , Daniel-jernigan , Christina-annunziata

Master(ing) Protocols for Randomized Umbrella and Platform Trials | Goodwin

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that...

Drug-administration , Product-development , Biological-product ,

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report on Health Care System's Role in Climate Crisis | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and...

Department-of-health , Committee-democrats , Biden-administration , National-advisory-child-health , Scientist-proposed-guidance-development-list , Ranking-member-of-the-senate-health , National-cancer-institute-clinical-trials , Compliance-team , Drug-administration , Human-services , Blood-institute-sickle-cell-disease-advisory-committee

Onderstepoort Biological Products vows to tackle animal vaccine scarcity crisis, ropes in EU experts

Onderstepoort Biological Products has encountered a series of formidable obstacles in recent times, but there is hope as the company has assured that, while there are still shortages of animal vaccines, this challenge will be resolved by August.

South-africa , Onderstepoort , Gauteng , Kwazulu , Eastern-cape , South-african , Natal , European-union , Meet-onderstepoort-biological-products , Onderstepoort-biological-products , Biological-products

Food security in SA now at serious risk due to vaccine shortages – Noko Masipa - POLITICS

DA MP says farmers have registered a 50% mortality rate among their sheep due to lack of bluetongue vaccine

South-africa , Onderstepoort , Gauteng , National-red-meat-producer-organisation , African-horse , Biological-product , African-horse-sickness ,

Virtual And Digital Health Digest - Healthcare

Welcome to the next installment of Arnold & Porter's Virtual and Digital Health Digest. This edition primarily covers March 2023 highlights across the virtual and digital health space.

United-states , Arnold-porter , European-union , Digital-virtual-health , Ai-device-software-functions , Digital-health , Product-development , Health-technologies-dhts-in-drug , Draft-guidance , Marketing-submission , Predetermined-change-control-plan , Device-software

FDA Announces The Discontinuation Of Certain COVID-19-Related Guidance Documents - Operational Impacts and Strategy

In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023...

United-states , Coagulation-systems-for-measurement-of-viscoelastic-properties , Health-care , Guidance-documents-expiring-with-the-public-health , Expiration-of-the-public-health-emergency , Development-of-monoclonal-antibody-products , Health-emergency , Public-health-emergency , Public-health-emergency-guidance , Enforcement-policy-for-digital-health-devices , Human-services

FDA Publishes Digital Health Technology Framework - Healthcare

In the context of the Framework, DHTs are "systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses."

Product-development-framework , Steering-committee , Framework-for-the-use-of-digital-health , Drug-administration , Drug-development-tool-qualification-program , Clinical-trials-for-drug-development , Oncology-center , Digital-health , Biological-product , Drug-evaluation , Biologics-evaluation

The Long (Un)Winding Road: FDA Maps Out How The End Of The Public Health Emergency Will Impact Its COVID-19 Policies - Operational Impacts and Strategy

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available...

Party-certification , Public-health-emergency-guidance , Human-services , Regulatory-affairs , Development-of-monoclonal-antibody-products-targeting , Animal-drug-development , Program-onsite-observation , Health-emergency-guidance-for-industry , Radiological-health , Public-health-emergency , Health-care

Purple Book Update – Regeneron's EYLEA (aflibercept) - Patent

Patents related to Regeneron's EYLEA (aflibercept) were recently added to the Purple Book.

Samsung-bioepis , Ocumension-theraputics , Amgen , Biological-product , Patent-transparency-act , Purple-book , Patent-dance , Shandong-boan-biological , Mondaq , Fda , Atent-dance , Purple-book