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CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis

The Pharma Data

The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. Make patients aware of potential risk of hypersensitivity reactions (day of, or several days after infusion, including signs/symptoms and recurrence) and provide package leaflet each time Benlysta administered.

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European Commission approves Benlysta for adult patients with active lupus nephritis

The Pharma Data

The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S. Make patients aware of potential risk of hypersensitivity reactions (day of, or several days after infusion, including signs/symptoms and recurrence) and provide package leaflet each time Benlysta administered.

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. 23 MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives Section 5.3.2

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

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Analysis Chemical Thank You What we expect the EPA to do in December 2023

Agency IQ

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C. 2020) (LEAN).

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Analysis Chemical Thank You What we expect the EPA to do in November 2023

Agency IQ

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.