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Regulatory Guidance Monthly Review - August 2022

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 August 2022.

 

Blog Image-Regulatory Guidanc eMonthly_FDAupdates-1

 

New FDA Guidance Documents

Bioresearch Monitoring Technical Conformance Guide (published 05-Aug-2022)

Download FDA Guidance

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (published 15-Aug-2022)

Download FDA Guidance

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers :  Guidance for Industry (published 26-Aug-2022)

Download FDA Guidance

 

 

FDA Draft Guidance

 

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry (published 02-Aug-2022)

Draft FDA Guidance

Charging for Investigational Drugs Under an IND: Questions and Answers (published 23-Aug-2022)

Draft FDA Guidance

Q2(R2) Validation of Analytical Procedures (published 26-Aug-2022)

Draft FDA Guidance

Q14 Analytical Procedure Development (published 26-Aug-2022)

Draft FDA Guidance

E11A Pediatric Extrapolation (published 26-Aug-2022)

Draft FDA Guidance

M12 Drug Interaction Studies (published 26-Aug-2022)

Draft FDA Guidance

 

 

Monthly FDA Approvals

 

Approval Date: 08/02/2022

Drug Name: CIMERLIBLA   #761165

Active Ingredients: RANIBIZUMAB-EQRN

Submission Classification*:

Review Priority**:

Company: COHERUS BIOSCIENCES INC

Approval Date: 08/03/2022

Drug Name: CALQUENCENDA   #216387

Active Ingredients: ACALABRUTINIB MALEATE

Submission Classification*: Type 3 - New Dosage Form

Review Priority**: Standard

Company: ASTRAZENECA

Approval Date: 08/08/2022

Drug Name: MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)NDA   #216359

Active Ingredients: MIDAZOLAM HYDROCHLORIDE

Submission Classification*: Type 5 - New Formulation or New Manufacturer

Review Priority**: Priority

Company: RAFA LABS LTD

Approval Date: 08/15/2022

Drug Name: EPINEPHRINENDA   #211363

Active Ingredients: EPINEPHRINE

Submission Classification*: Type 7 - Drug Already Marketed without Approved NDA

Review Priority**: Standard

Company: INTL MEDICATION SYS

Approval Date: 08/18/2022

Drug Name: AUVELITYNDA   #215430

Active Ingredients: BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Submission Classification*: Type 3 - New Dosage Form and Type 4 - New Combination

Review Priority**: Priority

Company: AXSOME

Approval Date: 08/24/2022

Drug Name: IMBRUVICANDA   #217003

Active Ingredients: IBRUTINIB

Submission Classification*: Type 5 - New Formulation or New Manufacturer

Review Priority**: Priority

Company: PHARMACYCLICS INC

Approval Date: 08/26/2022

Drug Name: VIVIMUSTANDA   #212209

Active Ingredients: BENDAMUSTINE HYDROCHLORIDE

Submission Classification*: Type 5 - New Formulation or New Manufacturer

Review Priority**: Standard

Company: SLAYBACK PHARMA LLC

 

Upcoming Advisory Committee Meetings


September 7, 2022 @ 12pm EDT- 6:30pm EDT: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee

September 22, 2022 @ 8:30am EDT- 5:00pm EDT: Vaccines and Related Biological Products Advisory Committee

September 22-23, 2022 @ 9:00am EDT to 1:15pm EDT : Meeting of the Oncologic Drugs Advisory Committee


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA clarifies reporting post-approval changes for disposable manufacturing materials (published 01-Aug-2022)

Read Article on RAPS.org

FDA official: Patients play an increasing role in rare disease drug development (published 01-Aug-2022)

Read Article on RAPS.org

Draft guidance: New options for submitting expedited safety reports for IND-exempt BA/BE studies (published 02-Aug-2022)

Read Article on RAPS.org

EMA, HMA outline evolution of DARWIN EU real-world database (published 02-Aug-2022)

Read Article on RAPS.org

EMA reports slow uptick in clinical trial applications submitted via CTIS portal (published 03-Aug-2022)

Read Article on RAPS.org

Studies highlight role of US patent system in limiting competition (published 05-Aug-2022)

Read Article on RAPS.org

Manufacturers that are not testing DSCSA data systems now are in 'big trouble' (published 08-Aug-2022)

Read Article on RAPS.org

Accelerated Approval: Experts weigh in on the role of RWE in confirmatory trials (published 08-Aug-2022)

Read Article on RAPS.org

FDA issues Jynneos EUA to stretch monkeypox vaccine supply (published 09-Aug-2022)

Read Article on RAPS.org

Study: Accelerated approval pathway working as intended in most cases (published 10-Aug-2022)

Read Article on RAPS.org

FDA Official: EU privacy regulations impede BIMO inspections, application reviews (published 10-Aug-2022)

Read Article on RAPS.org

FDA-led study highlights tradeoffs in drug promotion on social media (published 11-Aug-2022)

Read Article on RAPS.org

FDA blasts California firm for multiple GLP issues involving nonclinical studies (published 11-Aug-2022)

Read Article on RAPS.org

UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster (published 15-Aug-2022)

Read Article on RAPS.org

Study: Immune checkpoint inhibitors found to improve quality of life PROs (published 16-Aug-2022)

Read Article on RAPS.org

Study: Public funding was instrumental to early development of COVID therapeutics, vaccines (published 17-Aug-2022)

Read Article on RAPS.org

OIG reprimands NIH for not enforcing trial transparency requirements (published 18-Aug-2022)

Read Article on RAPS.org

Study: Most accelerated approval indications don’t add high therapeutic value (published 19-Aug-2022)

Read Article on RAPS.org

ICH signs off on carcinogenicity testing addendum (published 22-Aug-2022)

Read Article on RAPS.org

FDA allows sponsors to spread out costs in revised IND charging guidance (published 23-Aug-2022)

Read Article on RAPS.org

EMA reports steady rise in clinical trial applications registered in CTIS portal (published 23-Aug-2022)

Read Article on RAPS.org

Patient registries: EMA officials highlight opportunities in orphan drug development (published 25-Aug-2022)

Read Article on RAPS.org

EU issues long-awaited GMP Annex 1 revision (published 25 Aug 2022)

Read Article on RAPS.org

Stakeholders ask FDA to be more flexible on rescinding breakthrough drugs designations (published 26-Aug-2022)

Read Article on RAPS.org

Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2) (published 29-Aug-2022)

Read Article on RAPS.org

Study: 'Little incentive’ for drugmakers to complete confirmatory trials for accelerated approvals (published 29-Aug-2022)

Read Article on RAPS.org

EU adopts 10-part workplan to guide the acceleration of clinical trials (published 30-Aug-2022)

Read Article on RAPS.org

 

 


 

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