Regulatory News

News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration, News, US, FDA Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study
Regulatory Recon: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives; ANVISA Approves GW's Cannabis-Based Sativex (17 January 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging

The US Food and Drug Administration (FDA) last week finalized its guidance on repackaging drugs by pharmacies and registered outsourcing facilities and also issued a revised draft guidance detailing its policies on mixing, diluting and repackaging certain types of biological products outside of the scope of an approved biologics license application (BLA).

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags:
Drug Compounding With Bulk Substances: FDA Offers Interim Policies

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: Active pharmaceutical ingredients, Drugs, Crisis management, Quality, News, US, FDA Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy
EMA Reveals List of Eligible Industry Stakeholder Organizations

The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas.

Categories: Government affairs, News, Europe, EMA, EC, Business and Leadership Tags: drug industry stakeholders
NICE Halts Plans to Charge for Appraisals

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Reimbursement, News, Europe, EMA, MHRA, NICE Tags: Brexit, UK Life Sciences, ABPI, NICE
Regulatory Recon: Trump Promises 'Insurance for Everybody'; FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Further Explains Delay on LDT Guidance

Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward.

Categories: In vitro diagnostics, Medical Devices, News, US, FDA Tags: lab-developed tests, LDTs, FDA on lab tests
US Supreme Court to Review Biosimilar ‘Patent Dance’

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: Biologics and biotechnology, Compliance, Due Diligence, Government affairs, News, US, FDA Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS
Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

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: Combination products, Clinical, Compliance, Government affairs, News, US, FDA Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance
FDA Draft Guidance Looks to Help Speed New Generics to Market

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

Categories: Generic drugs, Government affairs, Labeling, Regulatory strategy, Regulatory intelligence, News, FDA Tags: RLD, generic drugs, ANDA, ANDA submission
Regulatory Recon: Trump Meets With Silicon Valley Insiders for FDA Pick; Lilly Defeats Teva in Alimta Patent Dispute (13 January 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

Categories: Medical Devices, Postmarket surveillance, Submission and registration, News, US, Europe, FDA, EC Tags: Adverse Event Reports, AER, Safety
FDA Offers Draft Guidance on New Pre-Request for Designation Process

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: Combination products, Submission and registration, News, US, FDA Tags: Pre-Request for Designation, Pre-RFD, Combination Products
ICH Offers Reflection Paper on Good Clinical Practice Revisions

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: Clinical, Quality, Regulatory strategy, Regulatory intelligence, News, US, Canada, Asia, ICH Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8
Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: Biologics and biotechnology, Compliance, Labeling, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance
FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).

Categories: In vitro diagnostics, Medical Devices, Clinical, News, US, CDRH Tags: Investigational Device Exemption, Final Guidance
180-Day Exclusivity for Generics: FDA Releases Draft Guidance

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

Categories: Generic drugs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: 180-day exclusivity, generic drugs, FDA guidance
Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

Categories: Biologics and biotechnology, Drugs, Clinical, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: endpoints, clinical trials, clinical guidance, FDA guidance
Regulatory Recon: Trump Meets with NIH Contenders; NICE Backs Novartis Kidney Cancer Drug (12 January 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA Tags: regulatory harmonization, ICMRA, Bayer, biologic quality standards
NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, News, US Tags: National Cancer Institute, NCI, NCI Formulary, Oncology
FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices

The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs).

Categories: Medical Devices, Postmarket surveillance, News, US, FDA Tags: Cybersecurity, Medical Device Cybersecurity, St. Jude Medical, MedSec, Muddy Waters Research, Merlin@home Transmitter
FDA and MHRA Break Down Foreign Inspection Data

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, Europe, FDA, MHRA Tags: foreign drug inspections, foreign device inspections
Trump Sides With HHS’ Burwell and Democrats on Drug Price Negotiations

President-elect Donald Trump on Wednesday opened his press conference with an unexpected shot at pharmaceutical companies and their lobbying groups on Capitol Hill, saying, "They’re getting away with murder."

Categories: Drugs, Government affairs, News, US Tags: Donald Trump, PEOTUS, Burwell, Medicare Part D, drug price negotiations
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