2024 Documentation Labelling 
European Pharmaceutical Review
JANUARY 25, 2024
This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.
GMPSOP
MARCH 30, 2024
Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.
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Big Molecule Watch
MAY 3, 2024
The guidance remains in draft form and, as with any FDA guidance document, it is not legally binding and, when final, will reflect FDA’s “current thinking” on this topic. The 60-day comment period for this revised draft guidance ends on 6/24/2024. Instructions for submitting comments to this guidance can be found here.
FDA Law Blog: Biosimilars
FEBRUARY 21, 2024
Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.
Big Molecule Watch
JULY 22, 2024
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines. requesting data and documents regarding their business and business practices. OptumRx, Inc.;
Express Pharma
OCTOBER 2, 2024
Speaking at the recent ASSOCHAM Annual Pharma Summit 2024, Secretary, Department of Pharmaceuticals, Dr Arunish Chawla’s review of the regulatory reforms needs to go hand in hand with the growth opportunities. Companies have also pointed out that QR codes are missing from these batches.
FDA Law Blog: Biosimilars
APRIL 25, 2023
The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. Loose Ends IDEs.
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