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The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

FDA Identifies Essential Medicines

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

Predicting Generic Drug Marketing Applications

FDA published guidance for submitting standardized study data in electronic format.

Guidance on Submitting Standardized Study Data 

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

The Department of Justice Files a Complaint Against Animal Health Company for the Distribution of Adulterated Animal Drugs

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

AstraZeneca and Daiichi Sankyo Granted Priority Review for Gastric Cancer sBLA

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

FDA Approves Remdesivir for Hospitalized Patients

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

FDA Vaccine Committee Meets About COVID-19 Vaccines

Donald Singer is senior microbiology technical consultant at Ecolab Life Sciences.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions. 

Refining Microbiological Control for Non-Sterile Products

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

Guidance on Annual Status Reports of Postmarketing Studies 

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA Finds CGMP Violations at Canadian Facility 

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.

Industry Backs Clear FDA Standards for COVID Vaccine Authorization

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

FDA Guidance on Treatments for Renal Cell Carcinoma

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?

Sean Milmo is a freelance writer based in Essex, UK.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Regulating with Flexibility: The Pandemic Effect

Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

Misleading messages contribute to eroding trust in public health agencies.

Fighting the (Dis)Information Pandemic

The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.

FDA Releases Guidance on Drugs for Treatment of Opioid Use Disorder

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Regulatory Authority Actions