Susan Haigney

The commission’s membership will help facilitate reach and impact for standards harmonization.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

Industry experts discuss best practices for certificates of analysis.

A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

Outsourcing partners are ready to fill the market need for greater cell therapies capacities.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.