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September 16, 2021
FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.
Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.
EFSA’s evaluation of risk in food products raises implications for drug product formulations.
September 15, 2021
A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.
Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.
September 10, 2021
NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.
August 27, 2021
Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.
August 24, 2021
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
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.
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.