Advarra

JULY 19, 2022

For more information on key components of a fit-for-purpose, phase-by-phase QMS guidance download Advarra’s whitepaper Steps to Implementing a Quality Management System. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Could you please confirm?

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The Pharma Data

DECEMBER 14, 2020

The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies. This contains such information that Cyxone AB is required to make public under the EU’s Market Abuse Regulation. The following files are available for download: View original content: [link].

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware.

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Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. In April 2023, the first update ( link is a direct download) from the ODTF indicated that it was working to develop a definition for orphan device.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

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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 ).

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The Pharma Data

NOVEMBER 2, 2020

To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Oncopeptides based on foreign tax regulations. The following files are available for download: View original content: [link].

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The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. recalled packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. ,

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Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

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The Pharma Data

MAY 15, 2021

So much so that studies have shown your brain can regulate force production without you ever having to move a muscle. This is an unbelievably exciting package… designed you so don’t risk a single cent putting it to the test in your own home. And, you get to KEEP anything and everything you’ve downloaded. If it doesn’t however….

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The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. View original content to download multimedia: [link]. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV. US Approval January 2021.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. While “strict products liability may apply to standardized and mass-downloaded software [it] does not apply to information or ‘expressive’ content.” Smith rejected plaintiff’s analogy between books and drug package inserts.

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