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Warning Letters: An Untapped Source for Understanding When Device Changes Require a New 510(k)

FDA Law Blog: Biosimilars

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Likewise, in a November 8, 2022 WL to Abbott Point of Care Ltd., See 21 C.F.R.

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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

While many buyers had pulled back in 2022 and 2023 to focus on improving operations, we are now seeing more interest from corporates now seeking targets to enhance inorganic revenue, improve product portfolios or acquire critical AI talent. Certain areas of technology like AI and Cyber are active.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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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. 22 ,23 Ultimately, these costs are absorbed by local hospitals, health care systems, and state and local governments.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 1

Express Pharma

Based on our on-ground experience, the following patterns are frequently observed: Design basis weaknesses: Facilities often lack well-documented scientific rationales or fail to present a robust justification for design choices, procedural controls, and process parameters.

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

5376, the Inflation Reduction Act of 2022: As Amended in the Nature of a Substitute (ERN22335) and Posted on the Website of the Senate Majority Leader on July 27, 2022 , August 3, 2022, https ://www.cbo.gov/system/files/2022- 08/hr5376_IR_Act_8-3-22.pdf. 15 Inflation Reduction Act of 2022 , Pub. 1818 (2022).