Regulatory Oversight and Compliance

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

Demand for new therapies and vaccines spotlights production challenges.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

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.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

FDA demands accurate manufacturing and test information to ensure product quality.

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

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.

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.

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

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Draft guidance from FDA includes information essential for the completion of ANDA applications.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

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

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

Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer.

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.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA clarifies stability data recommendations for abbreviated new drug applications.

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.