Quality Systems

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

The warning letter cited GMP violations for finished drug products.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

Reducing regulatory roadblocks requires more than the stroke of a pen.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

The authors look at challenges and considerations to continuously improve inspection efficiency.

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.

Supply chain risk monitoring is crucial for any company doing business today, and it doesn’t have to be expensive.

More life-sciences companies are starting to manage global suppliers holistically.

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

The presentation details the addition of triethylamine to the guideline on toxic solvents.