REMS

Lachman Consultant Services, Inc. / Blog / REMS
29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

By    Jun 29, 2020    ANDAs BLA Generics NDA New Drugs Regulatory Affairs REMS Safety

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

Read More
23
Mar

FDA to Exercise Enforcement Discretion for Certain Limited REMS ETASU Elements

By    Mar 23, 2020    BLA FDA Generics New Drugs Regulatory Affairs REMS

Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]

Read More

Subscribe to our Blog

Categories

Archives

2020 © Lachman Consultant Services, Inc.Terms and ConditionsPrivacy Policy