Regulatory Oversight and Compliance

Orion Corporation announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.

EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.

Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets because of concerns regarding product efficacy.

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?

MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.

cGMP deficiencies prompted FDA to withdraw approval for 31 Apotex ANDAs

Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.

CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.