Quality Systems

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

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The agency publishes draft guidance on assay development and validation for immunogenicity testing.

Instruments are introduced for elemental impurity analysis and materials identification.

Highly potent or cytotoxic drugs require special handling

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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.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 company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.

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

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.

Texture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

Consider the 3 Ps (product, process, and patient) when choosing a parenteral packaging material.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.

Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.

Understanding of the risks associated with FMEA is crucial in lot release testing.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.