Quality/GMPs

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

FDA can better monitor quality production of domestic versus foreign firms.

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.

Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.

The agency will be waiving fees for scientific advice for academia developing orphan drugs.

The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.

FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.

The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.

The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.

The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

Will efforts to limit all returns on investment drive biopharma companies away from developing much-needed interventions for COVID-19.

The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.

The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.

The agency has added a COVID-19 innovation resource page and an education resources page to its website.

The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.

Johnson & Johnson’s Janssen Pharmaceutical Companies has received a positive opinion in Europe for its two-dose Ebola vaccine regimen.

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Despite the clear danger of COVID-19 to global health, vaccine opponents have gained ground, as fearful populations lose faith in the capabilities of industry and government to protect public health.

The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

FDA and the US Congress support innovation and access to cheaper medicines.