Search Results for Combination Products

Showing 1 – 17

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

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

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

Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017) By Nick Paul Taylor - Published 28 March 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Asia regulatory roundup, fast-track approvals, combination products, antibiotic resistance

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

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

FDA Offers Draft Guidance on New Pre-Request for Designation Process By Michael Mezher - Published 12 January 2017

After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests.

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

Tags: Pre-Request for Designation, Pre-RFD, Combination Products

FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety By Zachary Brennan - Published 19 December 2016

More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products.

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

Tags: combo product rule, FDA postmarket regulations, postmarket safety of combination products

FDA Establishes New Process for Preliminary Combination Product Classification By Michael Mezher - Published 11 August 2016

Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated.

Categories: News, US, FDA, Combination products

Tags: Combination products, Request for designation, RFD, Pre-RFD

Practical Guidance for Regulatory Professionals on Combination Products By Suzette Roan, JD, John Towns, PhD - Published 05 February 2016

This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, IMDRF, Combination products, Research and development, Submission and registration

Tags: Combination products, Design validation, Risk management, IMDRF

Califf Endorses Report on Combination Products Intercenter Consults By Michael Mezher - Published 16 October 2015

In a letter dated Wednesday, US Food and Drug Administration (FDA) Commissioner nominee Robert Califf endorsed an internal report detailing recommendations for how FDA could improve reviews of combination products, but says that the agency is already in the midst of addressing the issues called out in the report.

Categories: News, US, CDER, CDRH, Biologics and biotechnology, Combination products, Communication, Drugs, Government affairs, Medical Devices, Submission and registration

Tags: Combination products, Intercenter consults

FDA Expresses Desire to Work With Industry on CGMPs for Combo Products By Zachary Brousseau - Published 15 April 2015

FDA officials and industry representatives discussed the agency’s draft guidance on current Good Manufacturing Practice (CGMP) for combination products during a workshop on the topic presented by RAPS and the Combination Products Coalition.

Categories: HTML, Video, Articles, Under RAPS, RAPS Events, US, FDA, RAPS, Combination products, Manufacturing

Tags: Food and Drug Administration, FDA, Weiner, combination products, combo products, CGMP, workshop, webcast, Combination Products Coalition

How do you Ensure the Proper Manufacture of a Combination Product? FDA Explains By Alexander Gaffney, RAC - Published 26 January 2015

New guidance issued by the US Food and Drug Administration (FDA) offers an extensive set of recommendations on how members of the pharmaceutical industry can comply with a rule regarding the proper manufacture of combination products.

Categories: News, US, FDA, Combination products, Manufacturing, Quality

Tags: Combination Products, CGMP, Quality, Guidance, Draft Guidance

DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers By Alexander Gaffney, RAC - Published 21 August 2014

In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law.

Categories: News, US, Distribution, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: DEA, Hydrocodone, Schedule II, Schedule III, Final Rule, Rescheduling, Hydrocodone Combination Products

Generic Drug-Device Combinations: A Framework for Understanding FDA Approval Requirements By Clark Sullivan, JD - Published 03 June 2014

As innovations in drug delivery systems continue to emerge, so do the number of drugs with a device component. These so-called drug-device combinations include many types of products regulated by the US Food and Drug Administration (FDA), such as drugs prepackaged in inhalers and auto-injectors, transdermal patch delivery systems and various types of kits.

Categories: Features, US, CDER, CDRH, Combination products, Generic drugs, Medical Devices

Tags: Combination Products, Generic Drugs, Drug Delivery Systems, Drug-Device Combinations