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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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Strategies for digital success in hospital pharmacy

Hospital Pharmacy Europe

In response to this, the Leeds Teaching Hospitals NHS Trust (LTHT) pharmacy team has recently launched its ‘Digital Induction’ document. Initial feedback has been overwhelmingly positive, leading to the creation of additional documents tailored for line managers and pharmacy students with specific digital needs.

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Top tips for effective digital transformation and closed loop medicines management

Hospital Pharmacy Europe

Right documentation. Int J Qual Health Care 2021 Nov 13;33(4). CLMM ensures that, across all stages of the process from prescription to bedside administration, including medication preparation, dispensing and distribution the six rights of medication administration are met: 1. Right patient 2. Right medication 3. Right dose 4.

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From ward manipulations to 3D printing: shaping the future of personalised medication

Hospital Pharmacy Europe

This, in turn, requires structured documentation, such as dedicated fields in electronic prescribing systems, where prescribers can specify critical preferences like flavour, texture or excipient restrictions, to ensure that each patient receives a safe and personalised formulation. Eur J Hosp Pharm 2021 Mar;28(2):76–82.

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ICH Q6B for Analytics

PharmTech

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals. 2022 11, 41-44 Greer, F and Easton, R.L.

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Psychiatric Medication Adherence in Patients Experiencing Homelessness

Pharmacy Times

Patients were excluded if they had a primary mental health diagnosis of a substance use disorder or no documented Behavioral Health Initial Assessment Form in the electronic medical record. Due to incomplete documentation, the MARS score could not be calculated for all the patients. 2021 DSM-5 diagnoses and new ICD-10-CM codes.

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CDC Report Finds No Connection Between Thimerosal and Autism

Drug Topics

The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines. Thimerosal is a mercury-containing compound that has been widely used as a preservative in some biological and drug products since the 1930s.

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