Susan Haigney

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

The program will improve access to adeno-associated virus gene therapy vectors.

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

Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.

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

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.

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The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public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

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

Environmental monitoring data can help keep sterile environments sterile.

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

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Data from environmental monitoring can assist in keeping sterile environments sterile.

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

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.

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The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best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

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.

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

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

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

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.