Regulatory Oversight and Compliance

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Oxular has been granted rare pediatric disease and orphan drug designations by the US FDA for its proprietary drug, OXU-003.

Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Misleading messages contribute to eroding trust in public health agencies.

The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Symbiosis has successfully completed a scheduled inspection by MHRA.

The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.

With little more than a month to go until the national election, President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.

FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.