Regulatory Oversight and Compliance

What Does the Retirement of Two Senior FDA Officials Mean for COVID-19 Vaccine Regulations?

September 01, 2021

Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.

Incyte and MorphoSys Receive EC Approval for Minjuvi in Combination Therapy for Lymphoma

September 01, 2021

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

FDA and Industry Map New R&D Initiatives under Next User Fee Program

August 31, 2021

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles

August 27, 2021

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

Investigational Radiopharmaceutical for the Treatment of Bone Cancer Receives FDA Clearance of IND

August 27, 2021

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

FDA Grants Orphan Drug Designation to Aerami Therapeutics’s Imatinib

August 27, 2021

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

EC Approves UCB’s Treatment for Moderate-to-Severe Plaque Psoriasis

August 27, 2021

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).

MHRA Approves Clinical Trial Application for Scancell’s Modi-1

August 26, 2021

MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company's Moditope platform.

Pfizer Vaccine Approval Key to Boosting Vaccination Rates

August 24, 2021

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

FDA Offers Guidance on How to Include Bioequivalence Info in ANDAs

August 24, 2021

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.