Regulatory Oversight and Compliance

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

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.

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

The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.

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

The agency publishes draft guidance on assay development and validation for immunogenicity testing.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

PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.

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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

FDA’s breakthrough drug initiative is more popular and successful than ever.

The agencies detail the results of their three-year collaboration.

The Office of Generic Drugs highlights the agency’s work to advance generic drugs.

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 campaign against opioid abuse opens door to more innovative therapies.

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

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.

Global outbreaks energize vaccine R&D and drive production modernization.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

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.

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.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.