It appears that the OGD has hit a new high for total approval actions in August, judging by the unofficial numbers gathered from the available FDA databases as of this morning. Yes, that’s right-a total of ninety-five approval actions (seventy-four full-approval and twenty-one tentative-approval actions), which eclipses the ninety-four total full- and tentative-approval actions (eight-four […]
Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]
The EU recently issued the comprehensive GMP Annex 1 for the manufacture of sterile drug products. This guidance is broad and thorough covering all aspects of sterile product manufacture. Under the Quality Control section, (10.5) the following is referenced: The sterility test applied to the finished product should only be regarded as the last in […]
While FDA has allowed charging for investigational drugs since the 1987 “Charging Rule” went into effect, the Agency has been responding to questions from industry ever since. In 2009, the FDA revised the Charging Rule itself. The revised guidance (here) discusses these changes and notes that the “FDA’s regulations on charging for investigational drugs under […]
Today, the FDA released an alert (here) warning of potential cross-compatibility issues with the use of autoinjectors for injection of the glatiramer used for the relapsing‑remitting form of multiple sclerosis. The alert is directed at patients, caregivers, and healthcare providers. The FDA says it has “has received reports that using an autoinjector that is not […]
Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here) which provides an overview of FDA’s Compounding Incidents Program. It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]
In an earlier post (here), we projected the June approval number to be 52 full approval actions and 19 tentative approval actions. This morning the FDA published its official approval actions as well as other metrics (here) and our projections were spot on. The total of 71 approval actions (52 + 19) were exactly what […]
The Medicines for Europe Annual Conference was held June 29 to July 1, 2022 in the beautiful seaside town of Sitges, Spain. While many topics were discussed, foremost on the minds of many attendees and speakers was the war in Ukraine. Frances Zipp, President and CEO of Lachman, gave the opening address for the afternoon […]
In a recently released publication on the FDA website entitled, An FDA Self-Audit of Continuous Manufacturing for Drug Products (here) the FDA relayed its experience with some quantified data and some estimates of savings from the use of the continuous manufacturing (CM) vs. batch manufacturing (BM) albeit, from a limited number of applications. Key take […]
When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]
