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After outcry, UnitedHealthcare softens prior authorization policy for colonoscopies

STAT

Instead, the company is adopting a different policy that it calls “advanced notification,” requiring physicians to let United know they’ll be performing certain gastrointestinal procedures and provide information such as why it’s needed and the patient’s medical history.

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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog: Biosimilars

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

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EMA guidance aims to prevent medicine shortages

European Pharmaceutical Review

There is a need to optimise the notifications of potential and actual shortages, including earlier submission of notifications in advance of potential shortages and improving the accuracy of the detail provided to maximise the opportunities to prevent potential shortages from being realised or limiting their impact,” the document concludes.

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FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog: Biosimilars

Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient. One key update to the regulation will require that facilities provide information to patients regarding the density of their breasts. Your breast tissue is not dense.

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Reclaim Time With Turn-Key Infusion Services

Amber

Providers With Us To Experience: More Time for Productivity – Your days are too busy to waste on hold. Customizable Updates – Monitor referrals through email notification, fax notification, or use our provider portal for real-time insight. You deserve a reliable partner.

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Pharma gives UCPMP the thumbs up, health activists cry foul

Express Pharma

Health activists raise doubts on pharma associations self-monitoring the code The notification of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 on March 12 has been welcomed by major pharma associations, while health activists allege it is a “whitewash.”

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FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings

LifeProNow

The FDA issued notice today to all manufacturers of opioid analgesics used in outpatient settings that they are required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter.

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