Regulatory Oversight and Compliance

The two agencies have set up a working group on involving patients in drug development.

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

The agency provides quality, development, manufacturing, and labeling recommendations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

The agency publishes three final guidance documents on drug compounding.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

The agency published a report on fostering the development of advanced therapy medicinal products.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.

Biomedical innovation legislation may stall in 2016.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.