The US Food and Drug Administration (FDA) issued a draft guidance for public consultation providing recommendations for drug makers on using the agency’s inactive ingredient database (IID) during drug development.
FDA released Draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use […]
The US Food and Drug Administration (FDA) released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling. This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for […]
MHRA’s New Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.
Prospective abbreviated new drug application (ANDA) applicants will be able to submit Pre-Assigned ANDA number requests via the CDER NextGen Portal. For Applicants with account holder account will be automatically updated with this Pre-Assigned ANDA number request functionality. To create a new account, go to the CDER NextGen Portal, under the “Sign In” section on the right […]
The US Food and Drug Administration (FDA) finalized guidance on conducting maximal usage trials (MUsT) to support the inclusion of an active ingredient in an OTC monograph.
The US Food and Drug Administration (FDA) confirmed the capability of two additional European Union (EU) Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019.
Quality Use of Medicines relies on clear medicine labels. To reduce medication errors, medicine labels need to be more consistent, with important information made more prominent and easier to read. Therapeutic Goods Administration has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice and are designed […]
The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with […]
After three years in the works, the US Food and Drug Administration launched redesigned and more customer-centric website at FDA.gov. “April 29 is the official launch date”. The new Food and Drug Administration website, which the agency said receives nearly five million visitors each month, will provide the public with health and safety information that […]