Regulatory Guidance Monthly Review - Oct 2021

October 2021 


Veristat_SM_October2021 Reg

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.

 

Blog Image-Regulatory Guidanc eMonthly_FDAupdates-1

 

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New Draft Guidance Documents:

 

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Draft Guidance for Industry (published 06-Oct-2021)

Download Draft FDA Guidance

 

Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Draft Guidance for Industry (published 21-Oct-2021)

Download Draft FDA Guidance

 

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Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry: Draft Guidance for Industry (published 29-Oct-2021)

Download Draft FDA Guidance

 

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


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA draft guidance outlines criteria for conducting benefit/risk assessments (published 01-Oct-2021)

Read Article on RAPS.org

 

FDA drafts safety reporting guidance for drug and device investigators (published 01-Oct-2021)

Read Article on RAPS.org

 

New guide to clinical trial lay summaries available for EU sponsors (published 05-Oct-2021)

Read Article on RAPS.org

 

ICH announces sign-off on good clinical practices guideline (published 07-Oct-2021)

Read Article on RAPS.org

 

FDA recognizes Memorial Sloan Kettering tumor variant database (published 07-Oct-2021)

Read Article on RAPS.org

 

Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines (published 08-Oct-2021)

Read Article on RAPS.org

 

ICH guideline proposes daily limits for seven mutagenic impurities (published 08-Oct-2021)

Read Article on RAPS.org

 

FDA’s accelerated approval program: Is change on the way? (published 11-Oct-2021)

Read Article on RAPS.org

 

FDA official breaks down novel excipient pilot program (published 11-Oct-2021)

Read Article on RAPS.org

 

New USP chapter details lifecycle approach to analytical testing (published 11-Oct-2021)

Read Article on RAPS.org

 

EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance (published 12-Oct-2021)

Read Article on RAPS.org

 

FDA warns companies for GMP violations, conducting trial without IND (published 13-Oct-2021)

Read Article on RAPS.org

Unanimous thumbs up from FDA committee for Moderna booster (published 14-Oct-2021)

Read Article on RAPS.org

CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz (published 15-Oct-2021)

Read Article on RAPS.org

FDA adcomm unanimous on J&J boosters for all (published 15-Oct-2021)

Read Article on RAPS.org

Cyltezo approved as interchangeable biosimilar with Humira (published 18-Oct-2021)

Read Article on RAPS.org

FDA says IRB review still needed for IVD studies involving human specimens (published 19-Oct-2021)

Read Article on RAPS.org

EMA shares lessons learned from biosimilars pilot (published 19-Oct-2021)

Read Article on RAPS.org

FDA shows jump in competitive generic approvals (published 20-Oct-2021)

Read Article on RAPS.org

HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures (published 21-Oct-2021)

Read Article on RAPS.org

FDA withdraws more than 200 ANDAs over unsubmitted annual reports (published 21-Oct-2021)

Read Article on RAPS.org

FDA drafts data standards guidance for RWD (published 22-Oct-2021)

Read Article on RAPS.org

ICH stakeholders contemplate initiative’s future upon its 30th anniversary (published 25-Oct-2021)

Read Article on RAPS.org

Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids (published 26-Oct-2021)

Read Article on RAPS.org

ICH Q12 guideline draws more comments from industry (published 27-Oct-2021)

Read Article on RAPS.org

OPDP plans more research on presentation of 'targeted' MoAs (published 27-Oct-2021)

Read Article on RAPS.org

New public-private consortium will tackle gene therapies for rare diseases (published 28-Oct-2021)

Read Article on RAPS.org

Improving transparency of regulatory data at EMA, Health Canada, FDA (published 29-Oct-2021)

Read Article on RAPS.org

FDA authorizes Pfizer COVID vaccine for younger kids (29-Oct-2021)

Read Article on RAPS.org

 


 

Explore-More-Image-1