Quality Systems

The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study.

FDA published guidance regarding the development of treatments for acute myeloid leukemia.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

FDA has approved Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Veklury (remdesivir) is an investigational antiviral drug that Gilead is developing to treat COVID-19.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The COVID-19 pandemic has highlighted the challenges and complications of sourcing, tracking, and testing materials for pharmaceuticals. Pharmaceutical Technology spoke with Joe DiMartino, Luminata solution manager at ACD/Labs about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

Ferring Pharmaceuticals US is voluntarily recalling DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL because of superpotency or high amounts of desmopressin.

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

As biopharma companies and research institutes work to develop vaccines against COVID-19, policy makers and health officials debate strategies for ensuring fair and equitable distribution of anticipated preventives.

The COVID-19 pandemic has raised several questions about the safety of the pharmaceutical materials supply chain. Is onshoring the answer?

Pharmaceutical Technology spoke with Matthew Woodcock, director of LLamasoft, a supply chain analytics company that assists companies in their decision-making and supply chain challenges, about the impact the COVID-19 pandemic has had on the pharmaceutical supply chain.

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.

Hiring the right quality consultant can provide expertise and save costs.