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.

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FDA Draft Guidance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)

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

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)
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FDA Official: EU privacy regulations impede BIMO inspections, application reviews (published 10-Aug-2022)
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FDA-led study highlights tradeoffs in drug promotion on social media (published 11-Aug-2022)
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FDA blasts California firm for multiple GLP issues involving nonclinical studies (published 11-Aug-2022)
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UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster (published 15-Aug-2022)
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Study: Immune checkpoint inhibitors found to improve quality of life PROs (published 16-Aug-2022)
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Study: Public funding was instrumental to early development of COVID therapeutics, vaccines (published 17-Aug-2022)
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OIG reprimands NIH for not enforcing trial transparency requirements (published 18-Aug-2022)
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Study: Most accelerated approval indications don’t add high therapeutic value (published 19-Aug-2022)
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ICH signs off on carcinogenicity testing addendum (published 22-Aug-2022)
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FDA allows sponsors to spread out costs in revised IND charging guidance (published 23-Aug-2022)
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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)
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EU issues long-awaited GMP Annex 1 revision (published 25 Aug 2022)
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Stakeholders ask FDA to be more flexible on rescinding breakthrough drugs designations (published 26-Aug-2022)
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Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2) (published 29-Aug-2022)
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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

• Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
• 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