Regulatory Guidance Monthly Review - July 2021

July 2021 


Veristat_SM_Blog part 2-2

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 2021.

 

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New FDA Guidance Documents:

 

Field Alert Report Submission: Questions and Answers Guidance for Industry (published 22July2021)

Download FDA Guidance

 

Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (published 07July2021)

Download FDA Guidance

 

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry (published 01July2021)

Download FDA Guidance

 

Evaluating Cancer Drugs in Patients with Central Nervous System Metastases (published 01July2021)

Download FDA Guidance

 

New Draft Guidance Documents:

 

Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry (published 28July2021)

Download Draft FDA Guidance

 

Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications (published 01July2021)

Download Draft FDA Guidance


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

EMA updates reflection paper on GMP responsibilities of marketing authorization holders (published 29July2021)

Read Article on RAPS.org

 

FDA approves Semglee as first biosimilar interchangeable insulin (published 28July2021)

Read Article on RAPS.org

 

FDA sets deadline for study data technical rejection criteria (published 28July2021)

Read Article on RAPS.org

 

EMA addresses comparative quality assessment methods (published 27July2021)

Read Article on RAPS.org

 

ICH releases widely anticipated guidance on continuous manufacturing (published 27July2021)

Read Article on RAPS.org

 

FDA’s revised MAPP outlines procedures for generic drug labeling changes (published 27July2021)

Read Article on RAPS.org

 

FDA declines to extend nitrosamine risk assessment deadline (published 26July2021)

Read Article on RAPS.org

 

EMA adopts guideline on quality documentation for drug-device combination products (published 26July2021)

Read Article on RAPS.org

 

FDA seeks new members for Patient Engagement Collaborative (published 23July2021)

Read Article on RAPS.org

 

FDA finalizes guidance on field alert reports (published 22July2021)

Read Article on RAPS.org

 

FDA seeks global shift to include pregnant women in medical research (published 21July2021)

Read Article on RAPS.org

 

House committee advances bills on advanced manufacturing, opioids and more (published 21July2021)

Read Article on RAPS.org

 

CBER targets four stem cell firms with untitled letters (published 20July2021)

Read Article on RAPS.org

 

AAM: Medicare Part D plans slow to adopt generics (published 19July2021)

Read Article on RAPS.org

 

Kineret under review by EMA for some COVID patients (published 19July2021)

Read Article on RAPS.org

 

PIC/S adopts guidance on PQS risk-based change management, COVID-19 risk assessments (published 16July2021)

Read Article on RAPS.org

 

MHRA announces streamlined clinical trial review process (published 16July 2021)

Read Article on RAPS.org

 

Industry consortium releases blueprint for DSCSA tracking systems (published 16July2021)

Read Article on RAPS.org

 

MDCG posts guidance on UDI integration within a QMS (published 15July2021)

Read Article on RAPS.org

 

Long-awaited ICH continuous manufacturing guideline coming soon (published 15July2021)

Read Article on RAPS.org

 

Upcoming ICH guidelines should ease post-approval changes for analytical methods ( published 14July2021)

Read Article on RAPS.org

 

MDCG offers guidance on IVDR codes (published 13July2021)

Read Article on RAPS.org

 

FDA sees different tactics were successful in established conditions pilot (published 13July2021)

Read Article on RAPS.org

 

EMA guidelines highlight changes to IMPs triggering notification to regulators (published 12July2021)

Read Article on RAPS.org

 

Biden’s competition order directs FDA on biosimilars, importation and OTC hearing aids (published 12July2021)

Read Article on RAPS.org

 

CBER Q&A addresses stem cell enforcement questions (published 12July2021)

Read Article on RAPS.org

 

Woodcock calls for investigation into Aduhelm approval (published 09July2021)

Read Article on RAPS.org

 

EMA's PRAC weighs in on more vaccine side effects (published 09July2021)

Read Article on RAPS.org

 

FDA trims Aduhelm's indicated population (published 08July2021)

Read Article on RAPS.org

 

Appeals court overturns FDA’s ban of electric shock device (published 08July2021)

Read Article on RAPS.org

 

FDA calls for new warning labels on hydroxyethyl starch products (published 08July2021)

Read Article on RAPS.org

 

EMA updates Q&A on nitrosamine assessment and testing (published 07July2021)

Read Article on RAPS.org

 

MDUFA V negotiations press on with breakdown over TPLC proposal (published 07July2021)

Read Article on RAPS.org

 

FDA finalizes guidance on studying CNS metastases in cancer trials (published 06July2021)

Read Article on RAPS.org

 

FDA finalizes long-awaited UDI guidance (published 06July2021)

Read Article on RAPS.org

 

PIC/S finalizes GMP data integrity guidance (published 02July2021)

Read Article on RAPS.org

 

DIA: Woodcock, other top officials tout benefits of master protocols, want momentum to continue post-COVID (published 02July2021)

Read Article on RAPS.org

 

FDA issues draft guidance for transdermal adhesion systems (published 01July2021)

Read Article on RAPS.org.

 

House Appropriations advances FDA funding bill (published 01July2021)

Read Article on RAPS.org

 

FDA issues final guidance on providing regulatory submissions in alternate electronic formats (published 01July2021)

Read Article on RAPS.org

 


 

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