Regulatory Oversight and Compliance

HHS Public Health Makes Statement on COVID-19 Booster Shots

August 24, 2021

HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.

FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech

August 24, 2021

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

WHO Head Reiterates Call for Two-Month COVID-19 Booster Moratorium

August 23, 2021

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

UK Regulator MHRA Approves Moderna COVID-19 Jab for Adolescents

August 20, 2021

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

Novartis Secures Chinese Approval for Pediatric Indication of Cosentyx

August 20, 2021

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

ICMRA Sets Out Recommendations on Regulation of Future Therapies Using AI

August 20, 2021

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 Commences Evaluation of RoActemra as COVID-19 Treatment

August 20, 2021

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

FDA User Fees to Rise and Fall as New Fee Agreements Move Forward

August 20, 2021

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.

Paratek Receives Orphan Drug Designation for NUZYRA Antibiotic

August 20, 2021

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

Industry Responds to the Latest NICE Methods Review

August 20, 2021

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