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Chief Medical Officer Summit -CMO 360°
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June 2021
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 June 2021.
New FDA Guidance Documents:
Providing Regulatory Submissions in Electronic Format -- Standardized Study Data (published 22June2021)
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products (published 21June2021)
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment (published 17June2021)
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (published 03June2021)
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (published 03June2021)
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (published 03June2021)
Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers (published 03June2021)
New Draft Guidance Documents:
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (published 25June2021)
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings (published 24June2021)
Core Patient-Reported Outcomes in Cancer Clinical Trials (published 09June2021)
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations (published 02June2021)
FDA studies: No post-ingestion NDMA from ranitidine (published 30June2021)
FDA focuses on efforts made to avert drug shortages in 2020 (published 30June2021)
FDA releases first Cures Act report on patient experience data in regulatory decision-making (published 30June2021)
FDA gives generics updates at DIA town hall (published 29June2021)
EC issues first COVID therapeutics portfolio (published 29June2021)
EMA gives procedural guidance on variant COVID vaccines (published 28June2021)
FDA releases new draft guidance on sponsor role for safety reporting requirements (published 25June2021)
House subcommittee proposes $257M increase for FDA in FY2022 (published 25June2021)
EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper (published 24June2021)
FDA calls for inclusion of patients with incurable cancers in oncology trials (published 24June2021)
FDA’s OGD hears ways to accelerate complex generic development (published 24June2021)
Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H (published 22June2021)
CDRH qualifies new LASIK patient-reported outcomes tool (published 22June2021)
EMA management board report: COVID coping, CTIS updates and more (published 21June2021)
FDA issues final guidance on CMC postapproval changes for biologics (published 21June2021)
FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs (published 21June2021)
MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’ (published 18June2021)
Unified Agenda: A look at FDA’s upcoming rulemaking (published 17June2021)
EMA updates COVID-19 vaccine risk management plans to reflect variant safety (published 17June2021)
PIC/S looks to adopt EU Annex on qualified persons, batch release (published 16June2021)
Recent ruling gives FDA ammunition against unapproved cell therapies (published 15June2021)
Regulatory science pilot floated in BsUFA III negotiations (published 15June2021)
Best practices and education for probiotics amid regulatory uncertainty (published 15June2021)
FDA launches global Generic Drug Cluster (published 14June2021)
ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards (published 14June2021)
Brexit, COVID-19 headline EMA’s 2020 annual report (published 14June2021)
FDA panel split on approach to COVID-19 vaccines for younger children (published 11June2021)
FDA to study disclosure information for accelerated approval products in oncology (published 11June2021)
FDA releases draft guidance on assessment of PROs for cancer trials (published 09June2021)
FDA disappointed with slow uptake of approvals for stem cell therapies (published 09June2021)
EMA preps for EU common standard on electronic product information (published 08June2021)
Biden administration outlines plan to address US supply chain vulnerabilities (published 08June2021)
FDA’s FY22 budget priorities: boost inspections, surveillance; avert device shortages (published 08June2021)
Pharmaceutical officials propose new USP harmonized chapter on visual inspections (published 07June2021)
FDA details plans for DSCSA implementation in four guidance’s (published 04June2021)
FDA issues new MAPP on reviewing color additives (published 04June2021)
Demand forecasting in a pandemic: New considerations from EMA (published 04June2021)
BsUFA talks progress on supplements, meetings and guidance development (published 03June2021)
FDA provides draft guidance for enteral tube-administered drugs (published 02June2021)
Biden’s first budget request seeks $6.5 billion for FDA (Published 01June2021)
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Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
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Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
- Download our COVID-19 Guide on Strategies 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