Regulatory Authority Actions

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Immuno-oncology drugs are demonstrating patient benefits, but growing resistant to the high cost has implications for patients, market access, and manufacturers.

The agency extends the indication of the drug in combination with bendamustine.

The agency holds a workshop to strengthen collaboration with healthcare providers.

The company voluntarily recalls product due to particulate matter.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.

The agency published guidance on data integrity as it is relates to CGMP compliance.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

The agency issues safety guidance to minimize medication errors relating to product design and container closure design.

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

The campaign against opioid abuse opens door to more innovative therapies.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.