News & Insights Search

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent draft guidance on the development of a plausible mechanism framework for individualized therapies to treat rare diseases.

The European Medicines Agency (EMA) has provided guidance to help manufacturers adhere to good manufacturing practices (GMPs) when using three-dimensional (3D) printing technology, also known as additive manufacturing, in the production of solid oral dosage forms.

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.

The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug development. The agency is urging companies to adopt new approach methodologies (NAMs), incorporating in vitro human-based systems, such as organs-on-chips and in silico modeling, to assess drug safety.

The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) characterization studies to establish bioequivalence in abbreviated new drug applications (ANDAs) for topical medications.

The US Food and Drug Administration (FDA) on Thursday finalized guidance to assist sponsors developing medical devices intended for weight loss at the premarket stage. This guidance provides information on non-clinical testing, clinical study design for these submissions, and outlines how the agency evaluates the benefit-risk analysis needed to support weight loss claims.

The European Medicines Agency (EMA) has published a concept paper outlining topics that it wants to address in a reflection paper on non-clinical development of microbiome-based medicinal products (MMP). The agency said the paper should address issues such as the diversity of MMPs and the different areas of the body they target.

The medical device industry has expressed concerns about the US Food and Drug Administration's revised proposals for resource allocations and enrollment for the Total Product Lifecycle (TAP) program 2.0 program as part of the negotiations for the Medical Device User Fee Amendments VI (MDUFA). Industry also supported extending benefits beyond enrolled products.

Senators and expert witnesses voiced concerns about the US Food and Drug Administration's (FDA) oversight of rare disease therapies during a hearing of the Senate Special Committee on Aging on Thursday. These concerns included claims of inconsistent review processes, the agency's failure to apply regulatory flexibility, and the issuance of nearly two dozen complete response letters (CRLs) for rare disease treatments since the start of 2025.

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has published a new guidance agenda that outlines the guidance it plans to release this year, including both new and revised guidance documents. This latest agenda features several additions to the agency's list.

During a meeting to commemorate Rare Disease Day on Monday, officials from the US Food and Drug Administration (FDA) highlighted the importance of collaboration among stakeholders, while FDA Commissioner Marty Makary touted recent FDA initiatives to speed the development of new drugs for rare diseases.

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations.

Pharmaceutical companies and EU industry groups pushed back against the expectation for sponsors to justify their choice to use adaptive clinical trial designs in the International Council on Harmonisation's E20 guidance on adaptive clinical trials in comments submitted to the European Medicines Agency (EMA).

The European Medicines Agency (EMA) has announced that its pilot program for the stepwise pediatric investigation plan (sPIP) has successfully supported timely pediatric development while maintaining scientific rigor. This program will be incorporated into the existing pediatric regulatory landscape.

The International Council on Harmonisation (ICH) announced the adoption of its M15 guideline, which aims to harmonize general principles and best practices for utilizing model-informed drug development (MIDD) to aid in drug development.

The European Medicines Agency (EMA) has released a guideline on assessing the quality of inhaled and nasal medicines, as well as a guideline on demonstrating therapeutic equivalence (TE) of orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disorder. Both guidelines will take effect on February 1.

Tina Kiang, director of the Division of Regulations and Guidance in the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality, emphasized that although artificial intelligence (AI) is a useful tool in many areas of pharmaceutical manufacturing, humans are ultimately responsible for making decisions based on its outputs.

Biosimilar industry groups have expressed support for a recent guidance from the US Food and Drug Administration (FDA) that recommends the elimination of comparative efficacy studies (CES) for most biosimilar products and instead would rely on comparative analytical assessments (CAAs) to demonstrate comparability.

More than half of medical device companies in the EU have reduced their product portfolios to cope with the complexities of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR), while 17% have stopped producing devices entirely due to high certification costs and administrative burden.

The European Medicines Agency (EMA) has published a revised guideline on the development of drugs aimed at treating peripheral arterial occlusive disease (PAOD) in the lower extremities. It will take effect on 30 June 2026.