Regulatory Oversight and Compliance

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.

The new drug offers rapid and sustained control of patients’ potassium levels.

The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.

Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.