Every briefing item, in one running record.
The full archive behind the Weekly GxP Briefing — FDA rules and notices, recalls, guidance, and regulatory milestones across every industry SPEQ covers. Each item links to its primary source.
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). The special controls that apply to the device type are identified in this order and will be p...
The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type are identified in this...
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of ethyl cellulose a...
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 30, 2026....
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 29, 2026....
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Francis Esteban Matos for a period of 5 years from importing or offering for import any drug into...
The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...
The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...
The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order...
The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression into class II (special controls). The special controls that apply to the device type are identified in this orde...
The Food and Drug Administration (FDA or we) is issuing an order to repeal the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. We have determined that the aut...
The Food and Drug Administration (FDA or we) is proposing to issue an order that would repeal the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data,...
The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development (Strategy Documen...
Failed Impurities/Degradation Specifications
Subpotent drug
Subpotent drug
Subpotent drug
cGMP deviations
Lack of Sterility Assurance
Subpotent drug
Subpotent drug
A Federal Register notice (23 Apr 2025) extended FDA CDER’s voluntary Quality Management Maturity prototype assessment protocol evaluation program into a third year, following 2024 assessments of nine establishments.
The deferred Annex 1 provision relating to lyophilizer transfer and loading became operative one year after the main text.
Q14 and revised Q2(R2) formalized lifecycle and QbD concepts for analytical procedure development and validation.
The revised Annex 1 introduced the mandatory Contamination Control Strategy (CCS) across the EU and PIC/S member states.
The revised Q9 guideline added guidance on formality, subjectivity and bias, and risk review for regulated quality decisions.
In November 2022 the Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously to recommend CDER establish a Quality Management Maturity rating program to help reduce drug shortages and recalls.
The GAMP 5 second edition updated computerized system validation guidance for cloud computing, agile delivery, and modern software.
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