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 Form 483 for Lupin's Goa Facility

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month.

Categories: Generic drugs, Manufacturing, News, US, India, FDA Tags: Form 483, Lupin
Regulatory Recon: FDA Approves Novartis' Rydapt for AML; Questions Raised Over UK Cancer Drugs Fund (28 April 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
EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

Categories: Biologics and biotechnology, Drugs, Crisis management, Government affairs, News, Europe, EMA, EC, MHRA Tags: Brexit, EMA headquarters, EMA move
CDER Officials: Nanomaterial Submissions on the Rise

A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise.

Categories: Biologics and biotechnology, Drugs Tags: Nanomaterials, Office of Pharmaceutical Quality, OPQ
House and Senate Revive Bill Targeting Generic Drug Delays

Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs. 

Categories: Generic drugs, Clinical, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: CREATES Act, generic drug delay, REMS, Leahy
European Regulatory Roundup: Dutch MEB Raises Concerns About use of ADHD Drug Ritalin in Adults (27 April 2017)

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

Categories: Drugs, Veterinary products, News, Europe, EMA Tags: European Regulatory Roundup, CVMP, MEB
Regulatory Recon: Criteria for New EMA Host Coming Saturday; Concerns Raised About Integrity of International Trials (27 April 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
Senate Committee Advances Gottlieb Nomination as FDA Commissioner

The Senate Health, Education, Labor & Pensions (HELP) committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA Tags: Gottlieb, Senate FDA, FDA commissioner
FDA Approves First Treatment for a Form of Batten Disease

The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV).

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Batten disease, priority review voucher, PRV, Stivarga, Brineura, Bayer, Biomarin
Supreme Court Weighs Biosimilar Patent Dance

All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary.

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags: Supreme Court, biosimilars, Novartis, Sandoz
House to Consider MDUFA Add-Ons

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package.

Categories: Medical Devices, News, FDA Tags: User Fees, Reauthorization, Energy & Commerce
Regulatory Recon: India Antitrust Regulator Probes Roche Over Herceptin; GSK CEO Walmsley Says Pharma is Top Priority (26 April 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
Senate HELP Committee Delays Vote on Gottlieb Nomination

Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA).

Categories: News, US, FDA Tags: Scott Gottlieb, Nomination, FDA Commissioner, Senate HELP Committee
Health Canada to go eCTD-only for Drug Applications

Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format.

Categories: Drugs, Submission and registration, News, Canada, Health Canada Tags: Electronic Common Technical Document, eCTD
Generic Drug Industry Group Seeks FDA Regulation Changes

The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce.

Categories: Generic drugs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: generic drug policy, AAM and FDA regulations, label changes for generics
FDA Warns 14 Companies for Selling Fake Cancer Treatments

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media.

Categories: News, US, FDA Tags: Warning Letters, Misbranded Drugs, Fake Cancer Treatments
Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Asia, MFDS, CDSCO, TGA Tags: Asia regulatory roundup, GMP applications, stents, antimicrobial resistance
Regulatory Recon: Fresenius to Buy Akorn, German Merck's Biosimilar Busienss; After Trial Failures OncoMed Cuts Half its Staff (25 April 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 Warns Teva API Plant in China

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Teva, warning letter, FDA inspections
Pharma Execs Seek Smooth and Quick Transition of EMA Headquarters Out of London

With an eye to avoiding public health issues during a transition period, executives from Novartis, Pfizer, Eli Lilly, Amgen and other companies are calling on the European Council to decide on the new headquarters location of the European Medicines Agency (EMA) “as early on as possibly, preferably at its meeting in June.”

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA, EC Tags: Brexit, EMA headquarters
FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles

In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline.

Categories: Drugs, News, US, FDA Tags: Doxycycline, Medical Countermeasures, MCM, Anthrax
FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs

After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained.

Categories: Drugs, Crisis management, Due Diligence, News, US, FDA Tags: sodium thiopental, execution drugs, FDA and state executions, misbranded drugs
Regulatory Recon: BD to Acquire Bard for $24B; WHO to Pilot GSK Malaria Vaccine (24 April 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 Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray

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: Combination products, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Narcan, opioid overdose, Narcan nasal spray, naloxone
FDA Approves 5th Biosimilar, 2nd for Remicade

The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications.

Categories: Biologics and biotechnology, News, US, FDA Tags: biosimilar, FDA approval
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