Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing quality issues. Joanne has over 20 years of experience covering the regulated pharmaceutical and medical device industries, and helped launch the “International Pharmaceutical Regulatory Monitor” and the “International Medical Device Regulatory Monitor”. Previously Joanne covered the mortgage finance industry and the mortgage capital markets, and employment and training programs. Before her forays into newsletter journalism, Joanne worked as a general assignment reporter for a twice-weekly newspaper in southern Maryland and an editorial assistant for “Insight” Magazine, published by “The Washington Times.”
Advertisement
Set Alert for Articles By Joanne S. Eglovitch

Latest From Joanne S. Eglovitch

FDA Final Rule Places Six Substances On 503A Bulks List; Rejects Four

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.

 

United States Manufacturing

How One Biotech Venture Is Breaking The Cost Barrier In Manufacturing MAbs For Infectious Diseases

Biotech official explains how creating partnerships with NGOs, using innovative cell cloning technology and cutting costs is allowing startup to develop new monoclonal antibody treatments for infectious diseases in developing countries, including a new MAb for Ebola.
Manufacturing Quality

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.

Manufacturing Quality

FDA Proposes To Rely On Industry-Driven Consensus Quality Standards In New Drug Reviews

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.

 

Manufacturing Quality

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.

Manufacturing Quality

FDA Announces Launch Of DSCSA Supply Chain Security Pilot Program

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.

Manufacturing Quality
See All
Advertisement
UsernamePublicRestriction

Register