Quality Systems

Articles

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

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

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

FDA Blasts Misleading Opioid Promotion

The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.

EMA Reviews Amfepramone Medicines

FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.

Guidance Issued on Investigational COVID-19 Convalescent Plasma

The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.

Fresenius Kabi Oncology Pleads Guilty to Concealing and Destroying Records Prior to FDA Inspection

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Recent Achievements, Maps Plans for Continued Progress

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients. 

Where Are the Therapeutics to Combat COVID-19?

The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

 FDA Grants Emergency Use Authorization to Eli Lilly COVID-19 Antibody Cocktail

The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers. 

FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Lymphoma Treatment

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. 

New Leadership for FDA Entangled in Politics

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

Florida Manufacturer Warned for Inadequate Written Procedures 

Videos

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

Bio/Pharma Industry: Beyond Politics and the Pandemic

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus. 

FDA Outlines Strategy to Address Virus Variants

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

FDA Sets Date for Advisory Meeting to Discuss Janssen COVID-19 Vaccine EUA

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. 

Will Democrats Squeeze Down Drug Prices?

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

European Medicines Agency Recommends AstraZeneca COVID-19 Vaccine for Authorization

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

Manufacturing Considerations for Cell and Gene Therapies During COVID-19

Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner. 

Regulatory Authority Actions