Quality/GMPs

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

President Obama unveils his “Precision Medicine Initiative”.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.

As ADCs move through the drug-development process, different analytical methods are often required.

Initiatives to speed drug development must pass Congress and special interest groups.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Investors are lining up for the biosimilars market as patents reach expiration and regulatory pathways are defined.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.

Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

Cosentyx (secukinumab) is the first IL-17A inhibitor for moderate-to-severe plaque psoriasis patients.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.