EMA Updated Post-Authorisation Safety Studies (PASS)
On 10 August 2020 the EMA updated post-authorisation safety studies.
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MHRA’s Expectations for Return to UK On-site Inspections
On 11 August 2020 the MHRA published the guidance for industry on planning to resume on-site UK risk-based GxP inspections in September.
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Male Breast Cancer: Developing Drugs for Treatment
On 12 August 2020 the FDA announced the availability of the guidance for industry.
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Drug-Drug Interaction Assessment for Therapeutic Proteins
On 12 August 2020 the FDA announced the availability of the draft guidance for industry.
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Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
On 12 August 2020 the FDA announced the availability of the guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.
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