Regulatory Oversight and Compliance

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

FDA cited the facility for violations of quality management and data integrity CGMPs.

FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

The agency released several new and revised guidance documents regarding product-specific generic drug development.

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

The agency released its report on pilot project to involve patients in the assessment of medicines.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.

CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

New study will reveal bio/pharma practices and performance on quality issues.

Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician’s reimbursement will be based on patient outcomes.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. after an inspection found the company failed to monitor and control quality.