Regulatory Authority Actions

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.

Agency guidance and industry standards aim to reduce lapses and improve quality operations.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

ICH detailed the highlights of the council’s June 2016 meeting.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

The agency cited the company for sterile manufacturing violations.

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 issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

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

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

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

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

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

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.