Susan Haigney

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The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug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

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

Dr. Reddy’s has gained exclusive rights to promote and distribute Sanofi’s vaccines in India.

The company is recalling one lot of the product because of the potential presence of silicone particulates.

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

Noramco Group will be an integrated North American-based API and supply chain services provider.

The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.

The European company has seen its business increase by 47% in North America.

The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.

The facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

FDA has published final guidance documents regarding validation and development of analytical procedures.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

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.

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

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

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.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

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

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.