Monthly Archives: September 2020

The Value of Patient Voices in Plain Language Summaries Webinar

2020-09-10T10:44:33+00:00

Plain language summaries (PLSs) aim to meet a need in the industry for clinical trial transparency in a way that is meaningful and understandable for patients and the general public. As the pharmaceutical industry steps up to meet this requirement, patient panels play a crucial role in ensuring that information shared by sponsors [...]

The Value of Patient Voices in Plain Language Summaries Webinar2020-09-10T10:44:33+00:00

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

2020-09-09T12:21:02+00:00

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Summary: The USFDA recently finalized the guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products”. This guidance addresses repackaging of prescription and [...]

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products2020-09-09T12:21:02+00:00