Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and is unchanged from a proposed rule. The agency allows six bulk drug substances to be compounded by traditional pharmacies and rejects four that it had considered for inclusion, overruling the objections of pharmacy groups that argued for retaining them on the compounding list.
FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments
FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.
FDA’s drug center has proposed a new program that would allow pharmaceutical manufacturers to attest that drug products submitted for review conform to certain consensus quality standards. The agency said that such a program would improve drug quality, encourage the development of emerging technology and ensure smoother drug reviews.
FDA Warning Letter Hits Distributor McKesson For Allowing Diversion Of Opioids And Other Medications
FDA has issued its first warning letter under DSCSA to San Francisco-based distributor McKesson Corp. for failing to exercise adequate control over products that were tampered with while stored in its facility. The firm was also chastised for its lax response to reports from pharmacies that opioids and other prescription drugs were removed from bottles and replaced with other drugs while the bottles were in its possession.
FDA is accepting applications from the pharmaceutical industry to pilot electronic tracking systems for prescription drugs in preparation for a Nov. 27, 2023, implementation deadline.