-
The Division of Applied Regulatory Science is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and develops and implements new regulatory review tools and approaches.
-
Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events. -
Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.
-
Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older
As with any medicine, the MHRA will keep the safety and effectiveness of brensocatib under close review.
-
Rare Diseases at FDA
The FDA works with many people and groups, such as patients, caregivers, and drug and device manufactures, to support rare disease product development. -
Made Fresh Salads, Inc. Recalls Assorted Flavors of Cream Cheese Because of Possible Health Risk
Made Fresh Salads, Inc. of Bay Shore, NY is recalling assorted flavors of cream cheese because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weaken -
PDUFA VI: Fiscal Years 2018 – 2022
PDUFA VI: Fiscal Years 2018 – 2022 -
MHRA statement on the PATHWAYS puberty blocker trial
With all complex clinical trials, MHRA’s top priority is the safety and wellbeing of the trial participants
-
Generic Drugs Forum (GDF) 2026 – 04/22/2026
FDA’s annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. Join us April 22-23, 2026. -
Aurobindo Pharma Limited, Unit VII – 2/10/2026
Aurobindo Pharma Limited, Unit VII – 2/10/2026. 1/27/2023. Country: India. Record Type: 483 -
Medicines: Get integrated scientific advice from the MHRA and NICE
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
-
Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA)
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
