Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
Firms that manufacture sterile drugs on traditional filling lines instead of using restricted access barriers or isolators risk tighter scrutiny from FDA inspectors, agency official says. Yet it remains unclear how much of a difference the increased oversight will make.
FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.
Drug compounding pharmacy Guardian Pharmacy Services was ordered to stop manufacturing sterile drugs after ignoring quality problems for too long, bringing to two the number of decrees the Justice Department has filed against drug compounding pharmacies so far this year, which at the current rate may exceed the two consent decrees filed in all of calendar year 2018. The action follows reports that patients administered eye injections of a drug compounded by Guardian during cataract surgery developed vision impairment.
US FDA warning letter instructed Pfizer to implement a global corrective and preventive action plan to address widespread data integrity problems. While the impact of the warning letter on the site is expected to be minimal due to its closure, the global impact on the company’s sterile drug operations could be significant.
New Manufacturing Technologies And Regulatory Convergence Expected To Improve Access In Developing Countries
The key to increasing access to biopharmaceuticals and vaccines in developing countries and to break affordability barriers is through advanced manufacturing platforms and regulatory partnerships such as AVAREF and through WHO's standards setting activities. Yet doubts about the continuing viability of the CPP in promoting access were expressed at recent industry meeting.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.