Regulatory Oversight

The agency clarified the process for development programs for regenerative medicine therapies.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

The guidance explains the process of applying for competitive generic therapy designation.

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.

Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.

Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.

In January 2019, a temporary measure reopened the US government until Feb. 15, 2019, allowing FDA to resume full operations. Failure to find a permanent solution could have dangerous ripple effects on patient safety and innovation, says Jim Nolan, CEO of InClinica.

The final part of the European Falsified Medicines Directive (EU FMD) is to come into force on Feb. 9, 2019, which means that all medicines within the European Union will need to comply with the safety features as laid out by the delegated regulation.

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.

As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘no deal’ scenario.

Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.

Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

A Memorandum of Understanding (MoU) has been signed by the UK’s MHRA and the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.

The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.