Clinical Research Solutions
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CGT) products is extremely complex. The choice of a reliable Contract...
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CVM GFI #245 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
July 2022 The purpose of this guidance is to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements....
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Orphan Drug Designations in the US and EU
What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...
Clinical Research Solutions
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security...
Clinical Research Solutions
Global regulators agree on key principles on adapting vaccines to tackle virus variants
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
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Clinical Pharmacology Considerations for Oligonucleotides
For the first time, the FDA has issued a draft guidance for industry on “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. Oligonucleotides are short single...
Clinical Research Solutions
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This...
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Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...
Clinical Research Solutions
How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”
On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...
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FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance...