Regulatory Authority Actions

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.

FDA issued a warning letter to the company for obtaining over-the-counter drugs made by foreign manufacturers that violated federal law.

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

Oncologist Stephen Hahn has been nominated for the top post, following the appointment of Brett Giroir as acting commissioner.

In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.

FDA readies more efficient oversight processes while advancing collaboration with Europe.

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.

The report focuses on information from stakeholders, published research, and economic analysis of market conditions from an analysis of drug shortage data and development of recommendations by the inter-agency Drug Shortage Task Force led by FDA.

Showing gains of 54% compared with 2018, results from a 2019 study showed that nearly three-quarters of pharma barcodes meet Drug Supply Chain Security Act requirements.

A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.

The agency’s implementation of the SUPPORT Act has included new guidance documents and actions to restrict illicit drugs entering the US.

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.

The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.

AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

The tables can be used for new drug applications, biologics license applications, and supplements to these applications.

FDA and DEA warn four website operators to stop illegally selling opioids.

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.

Falsified documents and manipulated test results prompt warnings and investigations.

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.