Regulatory Oversight and Compliance

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

Plans to update the European Union’s variation framework have been finalized.

The European pharma industry needs to be prepared for the new clinical data requirements.

A revised regulatory variation framework should make lifecycle management more efficient in Europe.

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

The Landos acquisition adds a lead asset in autoimmune and inflammatory disease to AbbVie's portfolio, while the company's ADC, ELAHERE, gets full FDA approval.

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.