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FDA Updates on Digital Health Plans, Software Pre-Certification Pilot By Michael Mezher - Published 27 July 2017

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health

ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data By Michael Mezher - Published 26 July 2017

The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection.

Categories: News, FDA, ICH, Clinical, Drugs

Tags: Safety Data, ICH, International Conference for Harmonization, E19

Pharmaceutical Cleaning Processes By John Godshalk, MSE, MBA - Published 26 July 2017

This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.

Categories: Features, FDA, WHO, Drugs

Tags: Cleaning, Washing, Rinsing, Cleaning Validation

Gottlieb: FDA Will Delay Sending Layoff Notices By Michael Mezher - Published 25 July 2017

In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then.

Categories: News, US, FDA, Government affairs

Tags: User Fee Reauthorization, Layoffs, Reduction in Force, RIF, Scott Gottlieb

FDA Finalizes GDUFA Q&A Guidance By Michael Mezher - Published 25 July 2017

The US Food and Drug Administration (FDA) on Tuesday finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues.

Categories: News, US, FDA, Compliance, Generic drugs, Submission and registration

Tags: Guidance, GDUFA, Abbreviated New Drug Application, Self-Identification

FDA Updates on Two ICH Guidelines By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: M4E(R2), Benefit-Risk Assessment, Efficacy, Q3C, Residual Solvents

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Medical Devices

Tags: Informed Consent, Minimal Risk, 21st Century Cures

FDA Clears First MRI Meant for Use in NICUs By Michael Mezher - Published 20 July 2017

The US Food and Drug Administration (FDA) on Thursday announced it has cleared the first magnetic resonance imaging (MRI) device intended to be used on newborns in neonatal intensive care units (NICUs).

Categories: News, FDA, Medical Devices

Tags: MRI, Magnetic Resonance Imaging, Embrace Neonatal MRI, NICU

CDRH Clarifies Process for Consensus Standard Recognition Requests By Michael Mezher - Published 20 July 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act.

Categories: News, US, FDA, Medical Devices

Tags: Consensus Standards, 21st Century Cures Act

FDA Warns Phototherapy Device Maker for Quality System Issues By Michael Mezher - Published 19 July 2017

The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March.

Categories: News, US, FDA, Medical Devices

Tags: Warning Letter, National Biological Corporation

FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings By Michael Mezher - Published 19 July 2017

The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023.

Categories: News, US, FDA, Distribution, Drugs, Packaging

Tags: DSCSA, Supply Chain

Senate Appropriations Bill Maintains FDA Funding for 2018 By Michael Mezher - Published 18 July 2017

The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Government affairs

Tags: Appropriations, FY2018, User Fees, Budget

Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017 By Michael Mezher - Published 18 July 2017

By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, MAPP

Update: Gottlieb Lays Out Plans to Bolster FDA's Staff By Michael Mezher - Published 17 July 2017

Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs.

Categories: News, US, FDA

Tags: Recruitment, Hiring, Vacancies, User Fees

FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities By Sharry Arora - Published 14 July 2017

The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Oral Solid Dosage, OSD, Inspections

Report Calls on FDA to Adopt New Standard for Reviewing Opioids By Michael Mezher - Published 14 July 2017

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

Categories: News, US, FDA, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Opioids, Opioid Epidemic

FDA: Lead Test Company May Have Violated Federal Law By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: News, US, CDRH, In vitro diagnostics

Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483

FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

Categories: News, US, FDA, Generic drugs, Research and development

Tags: bioequivalence guidance, FDA draft guidance

White House Doubles Down on Call to Fund FDA Entirely With Industry Fees By Zachary Brennan - Published 13 July 2017

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Medical Devices

Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill

FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

Categories: News, US, FDA, Biologics and biotechnology, Submission and registration

Tags: Avastin, Herceptin, Biosimilars, ADP 215, MYL-1401O

Regulatory Recon: FDA Rejects Drug Over Manufacturing Issues; Advisory Panel Backs Pfizer’s Mylotarg (12 July 2017) By Zachary Brennan - Published 12 July 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

House Passes Bill to Reauthorize FDA User Fee Programs By Zachary Brennan - Published 12 July 2017

In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDARA, FDA user fee reauthorization, user fees, BsUFA, MDUFA, GDUFA, PDUFA

FDA Considers Label Changes for Keytruda, Opdivo and Yervoy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: Opdivo, Keytruda, Yervoy, B-MS, Merck, uveitis

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess By Zachary Brennan - Published 11 July 2017

The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, user fee reauthorization, PDUFA, MDUFA, GDUFA, BsUFA