Regulatory Authority Actions

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.

FDA will delay its decision regarding the new drug application for panobinostat.

USP and ChP jointly host two-day meeting to strengthen cooperation.

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.

USP releases compendium of quality standards for compounded medicines.

Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.

The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.

FDA releases guidance specifying its preferred unique facility identifier system.

The authors take a look at some of the recent developments in the German pharmaceutical market.

The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.

An advisory committee recommends use of the first psoriasis therapy targeting IL-17A.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Demand for new therapies and vaccines spotlights production challenges.

FDA report details risk mitigation projects.