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EU seeks penalty from AstraZeneca for violating vaccine contract

A lawyer for the European Union has asked a Belgian court to impose large penalty on AstraZeneca for its failure to respect its COVID-19 vaccine supply contract with the region. During the first hearing on the case, the EU requested $12.2 per each day of vaccine delivery delay for each dose, as well as an additional fine of at least $12.1 million for each violation of contract that the judge decides. Reuters (5/27)

28/05/2021 COVID-19: latest updates (updated)

28/05/2021 News and press releases: First COVID-19 vaccine approved for children aged 12 to 15 in EU

28/05/2021 Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS , Virtual meeting, from 29/07/2021 to 29/07/2021

26/05/2021 Medical devices (updated)

26/05/2021 News and press releases: Medical Device Regulation comes into application

25/05/2021 Regulatory and procedural guideline: Validation checklist for Type II quality variations

25/05/2021 Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations (updated)

25/05/2021 Clinical Trials Information System (CTIS): training programme (updated)

25/05/2021 Presentation: How to respond to Requests for Information received during the evaluation of a CTA - CTIS Training Programme - Module 11

25/05/2021 Other: Checklist of required fields per application type - CTIS Training Programme - Module 10

25/05/2021 Presentation: How to create, submit and withdraw a clinical trial application - CTIS Training Programme - Module 10

25/05/2021 Presentation: Instructor exercise: How to evaluate an Initial clinical trial application: Assessment and decision CTIS training programme - Module 08

25/05/2021 COVID-19 treatments: research and development (updated)

25/05/2021 COVID-19 vaccines: research and development (updated)

21/05/2021 News and press releases: Vaxzevria: further advice on blood clots and low blood platelets

20/05/2021 Regulatory and procedural guideline: EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO) (updated)

20/05/2021 Other: CTIS training - List of acronyms

20/05/2021 Scientific guideline: Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - Step 2b

20/05/2021 ICH Q3C (R6) Residual solvents (updated)

19/05/2021 Template or form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance (updated)

19/05/2021 Regulatory and procedural guideline: EudraVigilance registration documents (updated)

19/05/2021 Regulatory and procedural guideline: EudraVigilance registration manual (updated)

19/05/2021 Other: New Organization First User QPPV/RP or Change of EU QPPV/RP (updated)

19/05/2021 Other: Step-by-step guide: Clinical Study Reports submission - CTIS training programme Module 13

19/05/2021 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)

19/05/2021 Other: Quick guide: Clinical Study Reports submission - CTIS Training Programme - Module 13

19/05/2021 Other: Instructor's guide: Clinical Study Reports submission - CTIS Training Programme - Module 13

19/05/2021 Other: FAQs: Clinical Study Reports submission - CTIS training programme Module 13

18/05/2021 COVID-19 vaccines: development, evaluation, approval and monitoring (updated)

On:

Inspection finds GMP violations at gene therapy facility

An inspection uncovered 13 deficiencies, including one critical and one major violation of good manufacturing practices, at Epitopoietic Research Corp.'s gene therapy facility in Schaijk, Netherlands. European regulators subsequently suspended distribution of Gliovac, an immunotherapy candidate for glioblastoma that combines autologous cells with cells extracted from donor gliomas. BioProcess International (5/3)

May 4, 2021 Untitled Letter - Ramos Chiropractic and Wellness Center (aka Rejuvenate Stem Cell Center)

Notice of Noncompliance

Acceleron Pharma

*Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

Domestic and Foreign Inspections

This month, the FDA released its Resiliency Roadmap for FDA Inspectional Oversight, which covers inspectional activities during the COVID-19 pandemic and a detailed plan of moving toward a more consistent state of operations – including the agency’s related priorities going forward.

The report also outlines inspections that the agency was unable to complete during the past year due to travel restrictions or inability to ensure the safety of our workforce or the workforces the agency regulates.

Identification of Medicinal Products: Path to Global Implementation

Guidance for Industry:

Bispecific Antibody Development Programs Guidance for Industry

ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry

*Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials

M9 Biopharmaceutics Classification System-Based Biowaivers

E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials

Q3D(R2) – Guideline for Elemental Impurities

S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals

Qualified Infectious Disease Product Designation Questions and Answers

FDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the Agency Cannot Inspect a Facility Due to Factors Including Travel Restrictions
 

FDA is providing additional information to drug manufacturers on circumstances under which the agency plans to approve an application, issue a complete response (CR) letter, or defer action when a site cannot be inspected due to factors including travel restrictions related to the public health emergency, and how FDA plans to prioritize inspections as travel restrictions are lifted.

While the number of inspections that can be conducted by FDA during the COVID-19 public health emergency are limited due to travel restrictions, FDA intends to continue using alternative tools, when appropriate, to evaluate facilities. Decisions regarding applications will be based on the totality of the information available to FDA, including information obtained from use of the alternative tools, which may include remote interactive evaluations as described in FDA’s recent guidance to industry. Based on an assessment of the product information provided in the application and based on available information about the facility or site, and as further explained in the revised guidance, FDA will take one of the following actions:

Planned Action

Facilities and Sites

Other FDA Drug Assessment Deficiencies

Approve the application

Available information supports the adequacy of the facilities and sites named in a pending application

No deficiencies have been identified and the application otherwise satisfies the requirements for approval.

Issue a CR letter with facility- or site-related deficiencies

Available information from a prior inspection or other source identifies deficiencies about the facility or site, but the required inspection cannot be completed due to factors including travel restrictions.

If any other deficiencies, are identified by the assessment team, the CR letter will include those deficiencies.

Issue a CR letter without facility or site deficiencies

An inspection is necessary because there is a lack of information about the facility or site but cannot be completed due to factors including travel restrictions (a facility or site deficiency will NOT be issued in this case; the facility or site issue will be a comment in the CR letter).

Other deficiencies are identified by the assessment team. The CR letter will contain those deficiencies.

Defer action (i.e., miss the goal date)

An inspection is necessary because there is a lack of information about a facility or site and cannot be completed due to factors including travel restrictions (a facility or site deficiency will NOT be issued in this case).

No deficiencies have been identified, and the application otherwise satisfies the requirements for approval.
 

For further information, please contact .

FDA will continue to review comments submitted to the docket for this guidance. This information, plus information on how FDA will prioritize inspections and additional clarifications, has been included in the revised guidance, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,” and posted to FDA’s web page, Manufacturing, Supply Chain, and Drug Inspections – COVID-19.

“Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,”

Medical Imaging Drugs Advisory Committee Charter

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry

CDER Pilot Grant Program: Standard Core Clinical Outcome Assessments (COAs) and their Related Endpoints (updated)

FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data

Today, the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) launched the “Send Your Oncology Research Questions to FDA” crowdsourcing challenge. OCE is using this challenge to provide an opportunity for interested stakeholders to submit ideas for research using pooled analyses of oncologic clinical trial data directly to FDA’s scientific staff.

Traditionally, FDA’s scientists have used pooled analyses to deepen understanding of efficacy of approved drugs, investigate relationships between different clinical endpoints used in regulatory submissions, and explore the potential for external controls to provide context for single arm trials. However, OCE wants to hear the questions you would like addressed with pooled analysis.

After this challenge ends, OCE may select questions for possible future analyses by FDA staff. If your research question is selected for further analysis, you will be recognized on the OCE website and social media, invited to a discussion with OCE leadership and honored at a virtual award ceremony.

Please note that individuals who submit research questions will not obtain access to data or collaborate in any new research studies initiated by FDA.

Submissions to this challenge must be received by June 4, 2021. Visit OCE's Crowdsourcing site for more information about how to submit your research idea to the challenge and examples of ideas that may be considered. All submissions and discussions on the site will be moderated by FDA staff.

On

Legislators blast Emergent officials at House hearing RF Today

Members of the US House of Representatives lambasted officials of Emergent BioSolutions for ignoring serious potential contamination and cleanliness problems at their facility, causing millions of COVID-19 vaccine doses to be thrown out.

Emergent was unequipped to produce both J&J and AstraZeneca COVID-19 vaccines, execs tell lawmakers

The manufacturing hold at Emergent's Baltimore Bayview plant could be coming to an end — report Endpoint News

Eli Lilly gets subpoena from DOJ related to N.J. site

The Department of Justice sent a subpoena to Eli Lilly and Company requesting certain documents related to its Branchburg, N.J., site that manufactures the COVID-19 drug bamlanivimab. Eli Lilly workers previously accused a factory executive of altering documents to downplay quality control issues at the site. Reuters (5/27)

Acceleron, under threat of fines, reports out a negative study RF Today

Acceleron had not corrected its failure to report in the interval between July 2020, when it received a pre-notice of its potential noncompliance, and the notice of noncompliance that made explicit the risk of monetary penalties or other enforcement actions.

CytoDyn shares plummet after FDA blasts the biotech for cherry-picking COVID-19 data Fierce Biotech

Sanofi accused of deleting emails on Zantac recalls

Sanofi deleted employee emails about a possible connection between an impurity in its heartburn medicine Zantac and cancer risks before the FDA banned the drug in 2020, according to court papers filed by attorneys representing former patients. Sanofi officials denied the accusation. FiercePharma (5/12)

FDA Threatens Drugmaker with Fines for Failing to Report Trial Results Aspen Alert

Acceleron Pharma has become the first drugmaker to face potential fines from the US FDA for failing to report clinical trial results to ClinicalTrials.gov. In a notice of noncompliance sent to Acceleron on April 27th, the FDA notified the Cambridge, MA-based drugmaker that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or other regulatory action including injunction or criminal prosecution. This comes as the FDA and the NIH have faced criticism that they are too lax in enforcing clinical trial reporting requirements established under Section 801 of the Food and Drug Administration Amendments Act of 2007 and later put into effect by a 2016 final rule. Learn More

Notice of Non-compliance Letter 4/27/2021

Eli Lilly faces employee complaints, FDA troubles at factory making COVID-19 drug: report Fierce Pharma

HHS cracks down on AstraZeneca, Eli Lilly, Novartis, Novo Nordisk and Sanofi for limiting access to discounted drugs under the 340B program Endpoint news

House committee uncovers how Humira’s price spiked by 470% as AbbVie execs cashed bonuses tied to the hikes Endpoint news

Incyte settles copay kickback allegations for $12.6M

Incyte admitted no wrongdoing in an agreement with the Justice Department to pay $12.6 million to settle allegations that it essentially gave patients kickbacks through a myelofibrosis patient assistance charity for cancer drug Jakafi. The department says Incyte's donations to Good Days covered Medicare and Tricare subscriber copays for Jakafi, but copay assistance from drugmakers is not legal under federal health programs, and Incyte also allegedly pressured the charity to assist patients taking Jakafi for conditions other than myelofibrosis. Reuters (5/5)

FDA won't complete planned domestic inspections this year

The FDA said it will be conducting less than half of planned drug and device domestic surveillance inspections for fiscal 2021 due to pandemic-related restrictions. The agency is unsure when it will be able to resume normal domestic inspections, as it "depends on what happens with the pandemic, the virus and whether variants emerge," said Frank Yiannas, the FDA's Deputy Commissioner for Food Policy and Response. Becker's Hospital Review (5/7)

*Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors [2021-05-06]

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2021-05-03]

Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents [2021-05-03]

*Policy on Individual(s) accompanying a health products inspector (POL-0141) Date issued and implemented: May 19, 2021

19/05/2021 Brexit and reference medicinal products — updated CMDh guidance

*HSE Cyber Security Incident 19May2021

The HSE and the wider health system has been targeted by a criminal ransomware attack.

A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health 29 April 2021

SNOMED International and ICH are announcing the release of important new maps between global medical terminologies MedDRA and SNOMED CT.

Blog

*Is your eSystem actually an eCRF (electronic case report form)? Posted on:11 May 2021

With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.

Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision Posted on:7 May 2021

The ICH Management Committee is taking a unique step to provide a status update on the revisions to this guideline, via a public virtual conference on 18 and 19 May 2021.

MHRA guidance on coronavirus (COVID-19) Updated: 28 May 2021

We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.

Published links to decision documents and press release on the approval of the COVID-19 Vaccine Janssen.

Notify the MHRA about a clinical investigation for a medical device Updated: 25 May 2021

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

MHRA guidance on coronavirus (COVID-19) Updated: 20 May 2021

We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.

Added link to news story on Pfizer/BioNTech COVID-19 vaccine shelf-life being extended from 5 to 31 days to 'Vaccines and vaccine safety' section.

Advertise your medicines Updated: 20 May 2021

How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.

MHRA draft guidance on the licensing of biosimilar products Updated: 10 May 2021

We want your comments on the clarity and wording of our new guidance

Guidance on licensing biosimilars, ATMPs and PMFs Updated: 10 May 2021

The way you apply to licence biological products has changed

StEM March 2021

The MHRA Stakeholder Engagement Meeting met virtually in March 2021 – minutes and presentations can be found below.

MHRA StEM March 2021 Slides (PDF, 585KB, 6 pages)

Minutes of the StEM March 2021 (PDF, 351KB, 6 pages)

Remote Monitoring and SDV - Experience of EFGCP (PDF, 570KB, 4 pages)

Remote Monitoring and SDV - Experience of RQA (PDF, 473KB, 2 pages)

Remote Monitoring and SDV - Experience of ACRO (PDF, 358KB, 3 pages)

Use of eConsent in Clinical Trials - EUCROF and eClinical Forum (PDF, 1.42MB, 6 pages)

Presentation: EU Medical Device Regulation: Implications for the TGA and Australia 18 May 2021

EU Medical Device Regulation changes and the implications for the TGA and Australia

Guidance on the management of GMP compliance signals 18 May 2021

Guidance on the management of GMP compliance signals for manufacturers or medicines and biologicals

CTTI has posted information regarding the “ICH E6 Guideline for Good Clinical Practice – Update on Progress”, including presentation materials, links to recordings of the sessions (held on 18th and 19th May 2021), etc.

Sanofi hit with charges of 'widespread' email deletion in legal saga stemming from Zantac recalls Fierce Pharma

WHO, ICMRA call on pharma to release clinical trial data

The World Health Organization and the International Coalition of Medicines Regulatory Authorities are calling on the drug industry to offer voluntary unrestricted access to clinical trial data for new medicines and vaccines without redaction of confidential information. "Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada," the groups said. Regulatory Focus (5/7), European Pharmaceutical Review (UK) (5/10)

Journal of Clinical Research Best Practices May 2021

GoodRx helps people afford drugs. But is it improving health care or profiting off a broken system? Fortune

Training bees to smell the coronavirus Bionity

A trained bee can detect an infected sample within a few seconds
Start-up InsectSense and Wageningen Bioveterinary Research have trained bees to extend their tongues when they smell the coronavirus. The coronavirus, like other diseases, causes metabolic changes in ...

Pfizer publishes clinical trial diversity data from past decade, showing there's much work to be done Endpoints News

AbbVie repeatedly hiked Humira, Imbruvica prices and abused patients to keep competitors at bay: report Fierce Pharma

How To Improve FDA Inspection Readiness And Outcomes By Mining Publicly Available Data By Penelope Przekop, MSQA, RQAP-GCP, and Valerie Przekop

Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

GxP Risk Assessment For Computerized Systems Article | By Bobby Bouthillette, Egnyte

In GxP environments, validating and documenting mission-critical systems are required to ensure the integrity of data and audit-readiness. Yet, given the number of systems used, it is unclear which electronic systems require validation and which do not. This checklist provides a framework for evaluating which software should or should not be validated.