Regulatory Authority Actions

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

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

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

The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

FDA releases guidance on ANDAs and PASs submissions to help applicants avoid deficiencies.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

The European system for assessing drugs will be used as a model internationally.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

FDA releases guidance documents and rules on requirements for compounding human drug products.

European Medicines Agency clarifies advanced-therapy medicinal products classification.

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.

Draft guidance from FDA includes information essential for the completion of ANDA applications.

Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

EMA publishes revised guideline on the acceptability of names for drugs.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

FDA issues complete response letter for Novartis' RLX030 for acute heart failure.

EMA opens registration for it's sixth annual workshop on pediatric drug research and development.

EMA and ECHA sign agreement to share information and work together on risk assessments.