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February 2020
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided in February 2020.
Finalized Draft Guidance Documents:
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff (Published 26Feb2020)
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (Published 21Feb2020)
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments Technical Specifications Document (Published 14Feb2020)
Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II) Guidance for Industry (Published 05Feb2020)
CHAPTER53– POST-MARKETING SURVEILLANCE ANDEPIDEMIOLOGY: HUMAN DRUG AND THERAPEUTIC BIOLOGICAL PRODUCTS (Published 01Feb2020)
New Draft Guidance Documents:
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry DRAFT GUIDANCE (Published 06Feb2020)
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry DRAFT GUIDANCE (Published 04Feb2020)
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry DRAFT GUIDANCE (Published 03Feb2020)
FDA NEWS RELEASE: Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics (Published 29Feb2020)
FDA Guidance Snapshots: Launch of a New Pilot (Published 28Feb2020)
FDA: Guidance Snapshot Pilot (Published 28Feb2020)
Why FDA Can’t Disclose the First Coronavirus-related Drug Shortage (Published 28Feb2020)
FDA STATEMENT: Coronavirus (COVID-19) Supply Chain Update (Published 27Feb2020)
OIG Finds Most Drugs can be Traced Through Supply Chain Thanks to DSCSA (Published 26Feb2020)
Hahn, FDA Center Directors Discuss What’s Necessary to Better Address Rare Diseases (Published 24Feb2020)
FDA Launches Searchable Purple Book (Published 24Feb2020)
SPEECH: Remarks by Dr. Hahn to the Public Meeting on Rare Diseases (Published 24Feb2020)
Drug Approvals: FDA Publishes Dataset of CDER Approvals Since 1985 (Published 21Feb2020)
FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents (Published 21Feb2020)
Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions (Published 20Feb2020)
Communicating the Importance of Regulatory to Various Stakeholders (Published 20Feb2020)
FDA STATEMENT: FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications (20Feb2020)
FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products (Published 20Feb2020)
Health Canada Begins Implementing eCTD for Clinical Trial Applications (Published 19Feb2020)
FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance (Published 19Feb2020)
ICH E9(R1) and S5(R3) to Take Effect in EU by End of July (Published 18Feb2020)
Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020 (Published 18Feb2020)
FDA Touts Generic Drug Research in 2019 (Published 18Feb2020)
Modernizing ClinicalTrials.gov: NIH Seeks Feedback (Published 17Feb2020)
CBER Plots New Draft Guidance in 2020 on Genome Editing, CAR-T Therapies (Published 14Feb2020)
EMA Begins Publishing All Health Professional Communications (Published 14Feb2020)
UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul (Published 13Feb2020)
Estimating the Probability of Regulatory Registration Success (Published 13Feb2020)
The Changing Role of the Regulatory Professional (12Feb2020)
ICH Plots Closer Collaboration With PIC/S (Published 11Feb2020)
ICH M9 to Take Effect in EU by End of July (11Feb2020)
How the Role of Regulatory Operations Professionals Will Evolve in the new Decade (Published 11Feb2020)
Tracking and Tracing Drugs and Vaccines: WHO Drafts New Policy (Published 10Feb2020)
Industry Groups Pitch FDA on Upcoming Clinical Outcome Assessments Guidance (Published 07Feb2020)
Writing Informed Consent Documents: A Balancing Act (Published 06Feb2020)
FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says (Published 06Feb2020)
FDA Discusses Standards Accreditation Pilot Ahead of Launch (Published 05Feb2020)
CDER Withdraws Third Product-Specific Draft Guidance in Almost 8 Years (Published 05Feb2020)
Why Understanding Regulatory Affairs is Important to key Company Decision Makers (Published 05Feb2020)
Industry Supports FDA’s Plans to Review Novel Excipients Outside of Applications (Published 04Feb2020)
Biologic and Biosimilar Misinformation: FDA Drafts Guidance (Published 03Feb2020)
Drug Quality: FDA Officials Discuss Perceptions (Published 03Feb2020)
FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans (Published 03Feb2020)
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER
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