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July 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 for both COVID-19 related and non-COVID-19 related programs in July 2020.
New FDA Guidance Documents:
Compliance Policy Guide CPG Sec. 280.100: Stability Requirements - Licensed In Vitro Diagnostic Products Guidance for FDA Staff (Published 31Jul2020)
Compliance Policy Guide CPG Sec. 280.110: Microbiological Control Requirements - Licensed AntiHuman Globulin & Blood Grouping Reagents Guidance for FDA Staff (Published 31Jul2020)
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry (Published 31Jul2020)
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Guidance for Industry (Published 29Jul2020)
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance for Industry (Published 29Jul2020)
Multiple Function Device Products: Policy and Considerations Guidance for Industry and Food and Drug Administration Staff (Published 29Jul2020)
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use Guidance for Industry and Food and Drug Administration Staff (Published 20Jul2020)
Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry and Food and Drug Administration Staff (Published 15Jul2020)
Cancer Clinical Trial Eligibility Criteria: Brain Metastases Guidance for Industry (Published 10Jul2020)
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients Guidance for Industry and IRBs (Published 10Jul2020)
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry (Published 10Jul2020)
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies Guidance for Industry (Published 10Jul2020)
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Immediately in Effect Guidance for Industry and Food and Drug Administration Staff (Published 01Jul2020)
New Draft Guidance Documents:
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry DRAFT GUIDANCE (Published 29Jul2020)
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry DRAFT GUIDANCE (Published 28Jul2020)
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry (Published 21Jul2020)
Global regulators agree on endpoints for COVID-19 therapeutics (Published 31Jul2020)
Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection (Published 31Jul2020)
FDA FY2021 user fee table (Published 31Jul2020)
Euro Regulatory Roundup: MHRA creates synthetic dataset to support COVID-19 research (Published 30Jul2020)
Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools (Published 29Jul2020)
Hahn says COVID-19 vaccines will be reviewed in ‘real time’ (Published 28Jul2020)
US regulations for regenerative medicine advanced therapies (Published 24Jul2020)
Euro Regulatory Roundup: EMA completes COVID-19 vaccine monitoring infrastructure (Published 23Jul2020)
FDA Proposes New Rule on Reporting Requirements (Published 23Jul2020)
Designing a biologics manufacturing facility: Early planning for success (Published 22Jul2020)
Six more months tacked onto regenerative medicine enforcement date (Published 20Jul2020)
FDA issues enforcement policy for coronavirus transport media (Published 20Jul2020)
Project Patient Voice a focus of ASCO-FDA workshop (Published 17Jul2020)
Regulation of advanced therapy medicinal products in the EU (Published 16Jul2020)
House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing (Published 16Jul2020)
Experts urge transparency, advisory committee review for COVID-19 vaccines (Published 14Jul2020)
Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir (Published 14Jul2020)
CBER withdraws 20 draft and final guidances (Published 13Jul2020)
Managing uncertainty: Regulatory reporting in multinational trials during COVID-19 (Published 13Jul2020)
EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules (Published 10Jul2020)
Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system (Published 10Jul2020)
NIH kicks off COVID-19 vaccine, monoclonal antibody research network (Published 08Jul2020)
Unified agenda: FDA publishes lengthy to-do list (Published 08Jul2020)
FDA clarifies informed consent provisions in COVID-19 clinical guidance (Published 07Jul2020)
Asia-Pacific Regulatory Roundup: TGA seeks data matrix code feedback (Published 07Jul2020)
Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test (Published 06Jul2020)
Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season (Published 02Jul2020)
FDA: Digital safety data submission to supplant PDFs (Published 01Jul2020)
EU agencies clarify pharmacovigilance expectations amid COVID-19 (Published 01Jul2020)
- Explore the Veristat COVID-19 Resource page
- Download our COVID-19 Guide on Strategie For Success During the COVID-19 Era
- 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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