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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing. 2021, May 2). Key Pillar of a Successful CDMO: Exceptional Regulatory Compliance. Societal CDMO. LGM Pharma.

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Texas lab owner pleads not guilty in $290M COVID testing fraud case

Beckers Hospital Review

According to court documents reviewed by Becker’s , Mr. Khan owned and operated labs in Texas as part of a conspiracy to submit false reimbursement claims for COVID-19 testing on samples that were never collected, mostly from uninsured patients.

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Investment Banking Trends: AI, US Fed rates, and private credit with Gaurav Bhasin

Fuld & Company Blog

in 2021 to $850B in 2023 according to PWC. This contrasts with sellers’ expectations of sustaining high valuation multiples from 2021 and 2022 into 2024, leading to a mismatch in valuation perspectives, making deal making difficult.

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Optimizing Your Drug Patent Strategy: A Comprehensive Guide for Pharmaceutical Companies

Drug Patent Watch

Proactive measures to protect your patents include: Regular patent portfolio reviews Monitoring competitor activities Maintaining detailed lab notebooks and documentation Implementing strong trade secret protections By staying vigilant, you can often prevent infringement before it occurs or strengthen your position if litigation becomes necessary.

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Renal Drug Dosing References

RX Note

Renal Pharmacotherapy, 2021 Renal Pharmacotherapy is a comprehensive listing of dosage recommendations of systemic medications for adult patients with compromised renal function. It provides detailed drug information (over 900 drug monographs) to assist healthcare professionals to safely dose medications in patients with kidney disease.

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NHC Submits Comments on CMS’ Proposed Rule on Marketplace Integrity and Affordability

Putting Patients First Blog

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation.