Regulatory Oversight and Compliance

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).

The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.

With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

EMA's CHMP has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of plaque psoriasis.

Otsuka Pharmaceuticals Europe has filed an initial marketing authorization application to the European Medicines Agency for voclosporin.

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.

FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.