IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations
On 4 January 2021 the FDA announced the availability of the draft guidance for sponsor-investigators. Comments may be submitted until 4 March 2021.
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Human Gene Therapy for Neurodegenerative Diseases
On 5 January 2021 the FDA announced the availability of the draft guidance for industry.
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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Safer Technologies Program for Medical Devices
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data
On 8 January 2021 the FDA released press on a sentence of medical doctor falsifying clinical trial data.
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