Joanne S. Eglovitch is a News, Regulatory Focus Editor at Regulatory Affairs Professionals Society (RAPS). She covers a wide range of topics within the realms of medicine and healthcare, pharmaceuticals, healthcare technology, and wellness, with a particular focus on pharmaceutical manufacturing and regulation. Joanne's insights and expertise are featured in various publications, solidifying her role as a key voice in the intersection of health and technology.
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Joanne's coverage predominantly focuses on government announcements and legal policy regulations related to health, healthcare, pharmaceuticals, drug manufacturing, and safety. She would likely be interested in pitches from experts who can provide insights or analysis on regulatory changes impacting the pharmaceutical industry or developments within the FDA.
Given her extensive coverage of FDA regulations and drug safety, Joanne may respond well to sources with firsthand experience in these areas. Pitches should offer detailed insights into how specific regulatory changes might impact businesses or patients within the healthcare sector.
While no specific geographic focus is mentioned for Joanne’s reporting, she seems to cover global health-related regulatory matters without a primary emphasis on any particular region.
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By: Joanne S. Eglovitch
An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound treatment and inflammatory conditions – be added to the list of drugs eligible for bulk compounding, known as the 503A Bulks List.
By: Joanne S. Eglovitch
By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked to review to the list of bulk drug substances that can be used in pharmacy compounding.
By: Joanne S. Eglovitch
The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for transitional listed status. Following evaluations, these authorities may transition to formal WHO-listed authorities (WLAs).
By: Joanne S. Eglovitch
The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient's performance status, laboratory values, and washout periods.
By: Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide products. These PSGs focus on peptide drugs used to treat conditions such as obesity, type 2 diabetes, osteoporosis, and macular degeneration.
By: Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products, such as prefilled syringes and autoinjectable pens.
By: Joanne S. Eglovitch
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.
By: Joanne S. Eglovitch
The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified logbooks to the agency. The agency also warned two other OTC firms for multiple violations of good manufacturing practice (GMP), including testing violations.
By: Joanne S. Eglovitch
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities.
By: Joanne S. Eglovitch
Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.
