Regulatory Authority Actions

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

FDA Commissioner Scott Gottlieb and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.

The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

The EU has announced that it has launched two WTO cases on unlawful import duties on ICT products and unlawful measures on pharmaceuticals, against India and Turkey, respectively.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

EMA has issued advice to healthcare professionals and patients on the potential increased risk of blood clots in the lungs and death with higher than recommended doses of Xeljanz (tofacitinib) in the treatment of rheumatoid arthritis (RA).

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.