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Filtering on: "topics combination products"

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Gottlieb: More Guidance on Complex Generics Coming By Zachary Brennan - Published 28 November 2017

The US Food and Drug Administration’s (FDA) difficulties in approving generic versions of complex products were front and center in Commissioner Scott Gottlieb’s comments at FDA’s Generic Drug Science Day on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: complex generics, Copaxone, Advair, EpiPen

Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways By Michael Mezher - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Devices Referencing Drugs, DRD, Combination Products

FDA Finalizes Combination Product Classification Guidance By Michael Mezher - Published 26 September 2017

The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices

Tags: Combination Products, Request for Designation, RFD, Classification, Final Guidance

UK’s MHRA Unveils Human Factors Guidance for Medical Devices By Zachary Brennan - Published 19 September 2017

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: News, Europe, EC, MHRA, Combination products, Government affairs, In vitro diagnostics, Medical Devices

Tags: human factors guidance for medical devices, MHRA guidance, MDR

FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components By Michael Mezher - Published 07 September 2017

The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan.

Categories: News, US, FDA, Combination products, Drugs

Tags: Meridian Medical Technologies, Pfizer, Mylan, EpiPen, Warning Letter

Regulatory Recon: Kite Submits First CAR-T Application in Europe; FDA Reviewers Raise Safety Concerns for J&J's RA Drug Sirukumab (31 July 2017) By Michael Mezher - Published 31 July 2017

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

Categories: News, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Regulatory intelligence

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

$500m Over 9 Years: FDA Details Plan for New 'Cures' Funds By Zachary Brennan - Published 07 July 2017

The US Food and Drug Administration (FDA) on Friday released a plan submitted to Congress for how it will use $500 million in potential new funding from the 21st Century Cures Act over the next nine fiscal years.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices

Tags: 21st Century Cures, Cures timeline, FDA plan for Cures funds

FDA, NCI to Collaborate Further on Cancer Research By Zachary Brennan - Published 26 June 2017

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

Categories: News, US, CDRH, Combination products, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: National Cancer Institute, proteogenomics, cancer research

FDA Officials Discuss Modernizing the Regulation of Combo Products By Zachary Brennan - Published 15 May 2017

As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: combination product regulation, combo products and FDA, 21st Century Cures

Biosimilars, 21st Century Cures Act, Clinical Trial Regulations, PDUFA, Global Regulatory Strategy and a Preview of May By Gloria Hall - Published 02 May 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in May.

Categories: Asia, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Submission and registration

Tags: Features, Regulatory Focus

FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray By Zachary Brennan - Published 24 April 2017

As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can revive those who have overdosed on opioids.

Categories: News, US, FDA, Combination products, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Narcan, opioid overdose, Narcan nasal spray, naloxone

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: J&J, Pfizer, Allergan, combination products and FDA

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products By Robert D. Cumming, Nancy W. Mathewson, Esq - Published 14 April 2017

This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.

Categories: Features, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices

Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA

Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees By Zachary Brennan - Published 14 April 2017

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, FDA user fees, drug review fees

FDA Officials Question Lack of New Cancer Drugs Developed in Combination With Radiation By Zachary Brennan - Published 13 April 2017

Although almost half of patients with cancer who are cured will have received radiation therapy as a component of their care, there is still a dearth of new therapies being developed in combination with radiation, officials from the US Food and Drug Administration (FDA) wrote in an article published this week.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: hematology and oncology, radiation therapy, cancer drugs

Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration By Zachary Brennan - Published 11 April 2017

For an agency that has announced its intention to release more than 100 draft guidance documents in 2017, the US Food and Drug Administration (FDA) is off to a slow start following President Donald Trump’s inauguration.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA guidance documents, OMB, draft guidance pharmaceuticals

CDRH Seeks Participants for Staff Training Program By Zachary Brennan - Published 24 March 2017

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

Categories: News, US, CDRH, Combination products, In vitro diagnostics, Medical Devices

Tags: ELP, CDRH training, staff training FDA devices

Law Firm Challenges FDA on Combination Product Appeals By Michael Mezher - Published 09 March 2017

Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Citizen Petition, Request for Designation, 21st Century Cures Act

EMA Weighs New Guideline on Quality Requirements for Combination Products By Zachary Brennan - Published 16 February 2017

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

Categories: News, Europe, EMA, Combination products, Quality

Tags: combination products, notified bodies, quality requirements

FDA Details Combination Product Postmarket Safety Reporting Requirements By Michael Mezher - Published 09 February 2017

The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting.

Categories: News, US, FDA, Combination products, Postmarket surveillance

Tags: Postmarketing Safety Reporting, PMSR, Combination Products, Record Retention

Challenges Surrounding the Development and Manufacturing of ATMPs Continue By Zachary Brennan - Published 03 February 2017

The experience of conducting clinical trials with advanced therapy medicinal products (ATMPs) in a real-world clinical setting, according to a new European Medicines Agency (EMA) summary of a conference discussion, can mean “battling multiple and often ridiculous barriers.”

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Blood, Combination products, Manufacturing

Tags: ATMPs, EMA conferences

FDA To Disclose Unredacted Advisory Committee Members' CVs By Zachary Brennan - Published 03 February 2017

In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Combination products, Drugs, Medical Devices

Tags: FDA advisory committees, conflict of interest

Regulatory Recon: New Global Pharma Head for GSK; Pharma CEOs Discuss Trump (20 January 2017) By Zachary Brennan - Published 20 January 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Combination products, Drugs, Human cell and tissue, Medical Devices

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

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance