Regulatory Authority Actions

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

The agency granted accelerated approval to Sarepta’s controversial DMD treatment, under the condition the company conduct additional studies to demonstrate efficacy.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency has recommended marketing authorization for Ibrance in the European Union.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

Sandoz won FDA approval for its biosimilar version of Enbrel.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

FDA issued a warning letter to College Pharmacy for multiple violations.

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

The Chinese facility was cited for data integrity violations.