Regulatory Oversight

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019.

CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

EC has granted approval of Pfizer’s VIZIMPRO (dacomitinib) as a monotherapy for the first-line treatment of adult patients with advanced or non-small cell lung cancer (NSCLC).

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

The EU has announced that it has launched two WTO cases on unlawful import duties on ICT products and unlawful measures on pharmaceuticals, against India and Turkey, respectively.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

FDA is moving to shift industry away from step-wise batch production.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.