Regulatory Oversight and Compliance

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Do patients get what they pay for when they demand cheaper drugs?

Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.

The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.

Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.

Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.

A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.

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

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

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.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.

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.

The approval expands the indications for Sprycel (dasatinib) in Europe.

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