Pink Sheet

US FDA's COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

By Nielsen Hobbs 29 Nov 2020

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Topic Coronavirus FDA

Medtech Insight

Guidance FDA Will Look Other Way If Manufacturers Modify Imaging Systems To Fight COVID19

By Shawn M. Schmitt 27 Nov 2020

The US agency has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images, as US health care workers fight the novel coronavirus.

Topic Coronavirus FDA

Pink Sheet

For Coronavirus US FDA Is At The Podium But Not On The Task Force

By Derrick Gingery 27 Nov 2020

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic FDA Vaccines Infectious Diseases Coronavirus

In Vivo

FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic

27 Nov 2020

FDA guidance updated in mid-April offered workarounds for trial sponsors attempting to conduct clinical studies in a time of travel limitations, staffing changes and heightened patient safety issues. For trials involving complex products and administration, such as cell and gene therapies, sponsors must determine whether modified protocols can still maintain trial integrity. If not, it may be time to press pause. 

Topic Coronavirus FDA

Medtech Insight

FDA Boosts Development Of OTC COVID-19 Tests With New Template

By Elizabeth Orr 27 Nov 2020

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Topic Coronavirus FDA Diagnostics

Pink Sheet

Webinar: FDA and its Commissioners

By Nielsen Hobbs 27 Nov 2020

The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?

Topic FDA

Medtech Insight

COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight

By Elizabeth Orr 27 Nov 2020

US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.

Topic Coronavirus FDA

Medtech Insight

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

By Shawn M. Schmitt 27 Nov 2020

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.

Topic Compliance FDA

Generics Bulletin

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

By Penelope MacRae 27 Nov 2020

The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.

Topic FDA Diabetes BioPharmaceutical