News & Insights Search

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.

The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.

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) sent a warning letter on 10 March to Novo Nordisk at its Plainsboro, NJ, site for a raft of postmarketing adverse drug experience (PADE) violations, including failing to report adverse events for patients taking the company's GLP-1 treatments indicated for diabetes and weight management.

Simone Pitts, a pharmaceutical investigator in the Office of Human and Animal Drug Inspectorate (OHADI) at the US Food and Drug Administration (FDA), stated that inadequate oversight of manufacturing operations by the quality control unit (QCU) was the top deviation identified in Form 483 inspection reports for pharmaceutical companies during FY 2024.

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections.

The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for existing drug and biologics dossiers to the common technical document (CTD) format described in the International Council for Harmonisation's (ICH) M4Q(R2) guideline.

BETHESDA, MD – The pharmaceutical industry and the US Food and Drug Administration (FDA) are collaborating on a structured data platform for submitting chemistry, manufacturing, and controls (CMC) information in new drug applications. This initiative is part of Project PRISM, which is the FDA's regulatory cloud submissions platform.

The US Food and Drug Administration (FDA) officially launched its PreCheck pilot program on Sunday and is now accepting applications from manufacturers who wish to participate. In announcing the program, the agency rejected the pharmaceutical industry's suggestions to allow existing facilities to participate in the program.

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.

US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency's Commissioner's National Priority Voucher (CNPV) program.

The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications.

WASHINGTON – The top compliance official at the US Food and Drug Administration's (FDA) biologics center said it is imperative for sponsors to schedule preapproval inspections (PAIs) at the midpoint of the review cycle, rather than waiting till later on in the process. Waiting till late in the review process could jeopardize an application, as sponsors will have less time to address any inspection issues.

Pharmaceutical industry representatives praised the US Food and Drug Administration's (FDA) decision to eliminate the requirement for comparative clinical studies for most biosimilars during a meeting on Wednesday kicking off the reauthorization of FDA's Biosimilar User Fee Amendments (BsUFA) program.

TGA has adopted about 370 international scientific guidelines as part of Australia's policy of aligning with comparable overseas regulatory counterparts wherever possible. While most of the guidelines in the latest batch would replace those already adopted, two European guidelines are new.

The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with the updated Good Manufacturing Practices (GMPs) for medical gases, which will take effect on 18 December 2025. These GMPs are tailored to the manufacturing, processing, and storage of medical gases.