Regulatory Focus Articles
Experts Discuss CDRH Proposals That May Require New Authorities
Fri, 24 May 2019 19:38:47 GMT
From a pre-certification (PreCert) approach on software as a medical device (SaMD) and laboratory-developed tests (LDTs) to cybersecurity and the 510(k) premarket review pathway, the US Food and Drug Administration (FDA) has set forth several proposals that may require additional statutory authority.
FDA Issues Drug Compounding Small Entity Compliance Guide
Fri, 24 May 2019 18:14:17 GMT
The US Food and Drug Administration (FDA) on Thursday issued a new questions and answers guidance intended to explain how small entities can comply with its recent final rule detailing the bulk drug substances that can be used in compounded drugs.
Industry Seeks More From FDA on Natural History Study Guidance
Fri, 24 May 2019 18:08:20 GMT
Merck, Lundbeck and Ionis Pharmaceuticals are seeking more details from the US Food and Drug Administration’s (FDA) draft guidance on natural history studies, including discussions of using third-party disease registries.
Recon: FDA Approves Novartis’ SMA Gene Therapy With $2.1M Price Tag
Fri, 24 May 2019 17:25:55 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
Fri, 24 May 2019 17:19:45 GMT
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Will the FDA Precertification Pilot Program Work?
Fri, 24 May 2019 16:00:00 GMT
This article discusses the new pilot program from FDA that aims to make it easier for qualified companies to move software through premarket review, while better leveraging postmarket data collection, and whether the program will work in practice as planned.
When a Retweet is Considered Promotional, MHRA Takes Action
Fri, 24 May 2019 15:14:57 GMT
Companies’ promotional use of social media can run afoul of regulators, even if it’s just the promotion of another account’s post, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reaffirmed Friday.
Experts Examine Impact of EU GDPR, CCPA on MedTech Sector
Thu, 23 May 2019 20:39:15 GMT
An expert panel at the AdvaMed Digital MedTech Conference in San Francisco on Wednesday discussed the impact on the medical technology sector from new legislation that enacted changes to privacy rights and data protection.
FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections
Thu, 23 May 2019 20:21:24 GMT
The US Food and Drug Administration (FDA) on Thursday cleared three new tests that can detect the presence of chlamydia and gonorrhea and authorized the marketing of a diagnostic to detect Zika virus immunoglobulin (IgM) antibodies in human blood.
Senate Bill to Cut Health Costs, Targets FDA Tweaks
Thu, 23 May 2019 19:46:29 GMT
The Senate Health, Education, Labor and Pensions (HELP) committee on Thursday unveiled a discussion draft of a new wide-ranging bill to help cut health care costs.
FTC Finds Dwindling Number of Anticompetitive Reverse Payment Deals
Thu, 23 May 2019 19:22:34 GMT
The Federal Trade Commission (FTC) on Thursday released a report on Hatch-Waxman patent settlements in FY 2016, finding an increase in the total number of settlements, but a major decrease in anticompetitive reverse payment settlements.
Recon: Gottlieb Returns to Biotech VC Firm; UN Creates New Ebola Chief Role
Thu, 23 May 2019 18:11:22 GMT
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700% Price Spike Spurs UK to Allege Four Pharma Companies Agreed to Restrict Competition
Thu, 23 May 2019 16:37:40 GMT
The UK’s Competition and Markets Authority (CMA) on Thursday alleged that Focus Pharmaceuticals, Medreich, Alliance Pharmaceuticals and Lexon have breached UK and EU law by entering into anti-competitive agreements that restricted the supply of the nausea and dizziness drug prochlorperazine.
EU Regulatory Roundup: EMA’s PRAC Calls for Withdrawal of Fenspiride Cough Medicines, Temporary Restrictions on Xeljanz
Thu, 23 May 2019 14:24:48 GMT
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
TGA and Health Canada Share Experiences With Mutually Relying on Other Inspectors’ Findings
Wed, 22 May 2019 20:44:07 GMT
Almost a year after the Pharmaceutical Inspection Co-operation Scheme (PIC/S) adopted a new guideline allowing regulators to rely on their peers’ good manufacturing practice (GMP) inspections, Health Canada and Australia’s Therapeutic Goods Administration (TGA) shared some early results.
House Committee Proposes 6% Increase in FDA Funding for FY 2020
Wed, 22 May 2019 20:23:16 GMT
The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.
FDA Solicits PreCert Software Developer Volunteers
Wed, 22 May 2019 19:40:25 GMT
The US Food and Drug Administration (FDA) on Wednesday put out a call for digital health software developers to participate in the agency’s software precertification (Pre-Cert) program as part of its 2019 Test Plan.
Spring Regulatory Agenda for FDA: What New Rulemakings are Coming
Wed, 22 May 2019 18:21:41 GMT
The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device companies, with new proposals related to the Right to Try law, investigational new drug (IND) application reporting requirements and amendments to patent term restoration.
Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M
Wed, 22 May 2019 17:33:56 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Global Medical Device Cybersecurity Compliance Requirements
Wed, 22 May 2019 16:00:00 GMT
This article discusses compliance requirements to maintain global medical device cybersecurity.