Pharma/Biotech – USA, Europe Regulatory News, Dec 2023 Vol. 1

USA

Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests

As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks – including hundreds in opposition that are identical that strongly diverge on whether the proposed rule will ensure test reliability or will burden labs with red tape and reduce the availability of tests for infectious diseases.

Understanding Drug’s Risks Is Focus of FDA Final Rule on DTC Drug Ads

While the FDA has a longstanding requirement that risk information must be included in television and radio prescription drug ads, the final rule the FDA just issued focuses on ways to help consumers notice, attend to, and understand the drug’s risks.

ICH Adopts Guideline on Viral Safety Evaluation of Biotechnology Products

The International Council for Harmonization (ICH) has adopted its Q5A(R2) guideline on viral safety evaluation of biotechnology products.

Senate Committee Passes Bill for ‘Legislative Improvements’ to PBM Landscape

The Senate Finance Committee voted 26-0 in favor of the Better Mental Health Care, Lower Drug Cost and Extenders Act which addresses pharmacy benefit manager (PBM) practices that sponsors Sen. Ron Wyden (D.-Ore.) and Sen. Mike Crapo (R.- Idaho) say drive up the cost of drugs.

Innovation in Cell and Gene Therapies Could Be Stifled From Draft Guidance Requirements, Commenters Say

An FDA draft guidance on reporting manufacturing changes in cellular and genetic therapy (CGT) products puts too much emphasis on clinical trials and neglects the benefits and efficacy of bridging studies, according to comments filed by 16 manufacturers and industry. The guidance, “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products,” proposes to require manufacturers of all investigational and approved CGTs to notify the agency of any changes in manufacturing that might alter the therapy’s safety or efficacy.

Using Collaboration and AI to Repurpose Already-Approved Medications for New Indications

At first, the idea of repurposing a drug seems so logical. A reasonable person could be forgiven for thinking this is already common practice. Since safety and efficacy have been shown in order to gain FDA approval to use a drug for a specific disease, that logic goes, wouldn’t researchers check to see what other diseases might be treated using such a drug?

EUROPE

EMA Expands Review of GLP-1 Agonists and Suicide, While Weight Loss Drug Market Looks to Expand

In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the popularity of these drugs also continues to expand. The drugs in EMA’s bull’s eye include Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide), Wegovy (semaglutide), Rybelsus (semaglutide), Victoza (liraglutide), and Xultophy (liraglutide plus basal insulin); Lilly’s Byetta (exenatide); AstraZeneca’s Bydureon (exenatide); Sanofi’s Lyxumia (lixisenatide) and Suliqua (insulin glargine plus lixisenatide); and Lilly’s Trulicity (dulaglutide).

List of medicines under additional monitoring

EMA published the list of medicines under additional monitoring includes medicines authorized in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means.

IRIS guide for applicants

EMA updated IRIS guide for applicants. This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, PRIME, marketing status reports, inspections and veterinary signal management) and related activities, or applications for Parallel Distribution procedures.

Parallel distribution: Regulatory and procedural guidance

The procedure described is intended to provide guidance and assist parallel distributors to fulfil their obligations, without prejudice to the interpretation of Community Directives and Regulations by the European Commission and/or European Court of Justice.

European Medicines Agency post-authorization procedural advice for users of the centralized procedure

EMA updated post-authorization procedural advice for users of the centralized procedure. How shall I present and submit my Type IA/ IAIN Variation, What procedure number will be given to grouped variation applications were updated in this document.

European Medicines Agency pre-authorization procedural advice for users of the centralized procedure

EMA updated pre-authorization procedural advice for users of the centralized procedure. How should I submit an Active Substance Master File (ASMF)? Is updated in the document.

Guide to information on human medicines evaluated by EMA

The European Medicines Agency (EMA) publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through to EMA’s evaluation of authorization applications, post-authorization changes, safety reviews and withdrawals of authorization. This guide describes the different types of information the Agency currently publishes for both centrally and non-centrally authorized medicines, as well as publication times and location on EMA’s website. It aims to help stakeholders know what kind of information to expect on medicines undergoing evaluations and other regulatory procedures.