Quality Systems

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.

The agency published an overview of marketing authorizations made in 2016.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

FDA published a flurry of guidance documents in late 2016.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

The company was cited by FDA for violations of sterile processing GMPs.