Quality Systems

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.

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

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

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

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

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

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

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.

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

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.