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FDA Releases Guideline Q&A on Nonclinical Safety Studies for Pharmaceuticals

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The US Food and Drug Administration (FDA) has released for comment an extensive question and answer document generated by the International Conference on Harmonisation (ICH) that is intended to Read More...

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ICH

ICH M3 Guideline

M3(R2)

Nonclinical

Safety

Trials

FDA Releases Draft Guidance for Veterinary Trials

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The US Food and Drug Administration’s Center for Veterinary Medicine (CVM) has released a draft guidance detailing best practices for setting active controls in animal studies used to demonstrate Read More...

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Active Controls

Animals

CVM

Draft Guidance

FDA

Nonclinical

Non-Inferiority

Veterinary

Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study

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Merck Sharp and Dohme Corp.’s global director of regulatory affairs received a warning letter on 17 February from the US Food and Drug Administration warning Merck that it had failed to complete an Read More...

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FDA

Janumet

Januvia

Letter

Merck

Merck Sharp and Dohme Corp

Misbranded

Nonclinical

Postmarketing

Study

Warning

warning letter

CBER Announces Electronic Submission Pilot Program

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The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) announced 28 February that it intends to conduct a pilot evaluation program for a new electronic data Read More...

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CBER

CDISC

Data

Electronic

FDA

IND

Nonclinical

Pilot

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Study

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FDA Releases Guideline Q&A on Nonclinical Safety Studies for Pharmaceuticals

FDA Releases Draft Guidance for Veterinary Trials

Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study

CBER Announces Electronic Submission Pilot Program

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