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Biotechgate Digital Partnering 2023
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October 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 October 2021.
New FDA Guidance Documents:
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for Industry (published 29-Oct-2021)
Download FDA Guidance
New Draft Guidance Documents:
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Draft Guidance for Industry (published 06-Oct-2021)
Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Draft Guidance for Industry (published 21-Oct-2021)
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry: Draft Guidance for Industry (published 29-Oct-2021)
Monthly FDA Approvals:
SERTRALINE HYDROCHLORIDENDA #215133
Type 3-New Dosage Form
ALMATICA
Approved on 04-Oct-2021
TAVNEOSNDA #214487
Type 1 - New Molecular Entity
CHEMOCENTRYX
Approved on 07-Oct-2021
ZIMHINDA #212854
Type 5 - New Formulation or New Manufacturer
ADAMIS PHARMS CORP
Approved on 15-Oct-2021
SEGLENTISNDA #213426
Type 4 - New Combination
ESTEVE
Approved on 15-Oct-2021
TYRVAYANDA #213978
Type 3 - New Dosage Form
OYSTER POINT PHARMA
Approved on 15-Oct-2021
TASCENSO ODTNDA #214962
No Classification
HANDA NEUROSCIENCE LLC
Approved on 18-Oct-2021
XIPERENDA #211950
Type 3 - New Dosage Form
CLEARSIDE BIOMEDICAL, INC
Approved on 22-Oct-2021
SUSVIMOBLA #761197
No Classification
GENENTECH INC
Approved on 22-Oct-2021
VUITYNDA #214028
Type 5 - New Formulation or New Manufacturer
ABBVIE INC
Approved on 28-Oct-2021
DILTIAZEM HYDROCHLORIDENDA #215252
Type 5 - New Formulation or New Manufacturer
EXELA PHARMA
Approved on 28-Oct-2021
SCEMBLIXNDA #215358
Type 1 - New Molecular Entity
NOVARTIS PHARMS CORP
Approved on 29-Oct-2021
FDA draft guidance outlines criteria for conducting benefit/risk assessments (published 01-Oct-2021)
FDA drafts safety reporting guidance for drug and device investigators (published 01-Oct-2021)
New guide to clinical trial lay summaries available for EU sponsors (published 05-Oct-2021)
ICH announces sign-off on good clinical practices guideline (published 07-Oct-2021)
FDA recognizes Memorial Sloan Kettering tumor variant database (published 07-Oct-2021)
Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines (published 08-Oct-2021)
ICH guideline proposes daily limits for seven mutagenic impurities (published 08-Oct-2021)
FDA’s accelerated approval program: Is change on the way? (published 11-Oct-2021)
FDA official breaks down novel excipient pilot program (published 11-Oct-2021)
New USP chapter details lifecycle approach to analytical testing (published 11-Oct-2021)
EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance (published 12-Oct-2021)
FDA warns companies for GMP violations, conducting trial without IND (published 13-Oct-2021)
Unanimous thumbs up from FDA committee for Moderna booster (published 14-Oct-2021)
CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz (published 15-Oct-2021)
FDA adcomm unanimous on J&J boosters for all (published 15-Oct-2021)
Cyltezo approved as interchangeable biosimilar with Humira (published 18-Oct-2021)
FDA says IRB review still needed for IVD studies involving human specimens (published 19-Oct-2021)
EMA shares lessons learned from biosimilars pilot (published 19-Oct-2021)
FDA shows jump in competitive generic approvals (published 20-Oct-2021)
HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures (published 21-Oct-2021)
FDA withdraws more than 200 ANDAs over unsubmitted annual reports (published 21-Oct-2021)
FDA drafts data standards guidance for RWD (published 22-Oct-2021)
ICH stakeholders contemplate initiative’s future upon its 30th anniversary (published 25-Oct-2021)
Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids (published 26-Oct-2021)
ICH Q12 guideline draws more comments from industry (published 27-Oct-2021)
OPDP plans more research on presentation of 'targeted' MoAs (published 27-Oct-2021)
New public-private consortium will tackle gene therapies for rare diseases (published 28-Oct-2021)
Improving transparency of regulatory data at EMA, Health Canada, FDA (published 29-Oct-2021)
FDA authorizes Pfizer COVID vaccine for younger kids (29-Oct-2021)
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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