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.

EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, News, Europe, EMA Tags: PRIME, Priority Medicines
European Commission: Cranberry Products Are Not Medical Devices

The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."

Categories: Medical Devices, News, Europe, EMA, EC Tags: cranberries, UTIs, bladder infections, medical devices and cranberries
Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review; UnitedHealth, Merck Sign Pact to Explore Value-Based Payments (26 May 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, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, Europe, Asia, FDA, EMA, PMDA Tags: antimicrobial resistance, antibiotic resistance, new antibiotics
FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.

Categories: Biologics and biotechnology, Submission and registration, News, US, FDA Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar
Copaxone Generics: Who Will Win First Filer Exclusivity?

Generic versions of Teva’s multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic reveals an unusual and complex situation.

Categories: Generic drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's
Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming

US Food and Drug Administration (FDA) commissioner Scott Gottlieb was in the hot seat on Thursday to defend President Donald Trump's budget plan to the House appropriations committee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed in the budget and revealed that FDA as of Thursday is no longer subject to a hiring freeze.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA Tags: Scott Gottlieb, FDA budget 2018, FDA user fees, drug prices
Regulatory Recon: GW Set to File Cannabis-Based Epilepsy Drug; Roche, Biogen Looking Into Report of Rare Brain Infection in MS Patient (25 May 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: Merck Accused of Blocking Remicade Biosimilars (25 May 2017)

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

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA, EC, MHRA Tags: Remicade biosimilar, ENVI, whistleblowers
FDA Cracks Down on TV Ad for Prescription Weight Loss Drug

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television ad that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl).

Categories: Drugs, Government affairs, News, US, FDA, Advertising and Promotion Tags: OPDP, Contrave, untitled letter, drug advertisements, TV drug ads
Challenges Providing Pharmaceutical Products to Syrian Refugees

This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.

Categories: Drugs, Crisis management, Submission and registration, Features, Middle East, WHO Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF
Senator Seeks More Info From Mallinckrodt on Price Increases of Acetaminophen Injection

Sen. Claire McCaskill (D-MO) late last week sent a letter to the CEO of Mallinckrodt seeking more information on price increases of its injectable version of acetaminophen as hospitals reported millions in increased costs.

Categories: Tags: Mallinckrodt, McCaskill, Ofirmev, acetaminophen
Regulatory Recon: FDA Panel Backs Puma Breast Cancer Drug; Biogen MS Drug Fampyra Picks up Full EU Approval (24 May 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Issues 483 to Repro-Med Over Reporting, Quality Systems Issues

The US Food and Drug Administration (FDA) has issued an inspection report detailing eight observations to medical device maker Repro-Med Systems following a seven-day inspection of the company's Chester, NY facility in late 2016.

Categories: Medical Devices, News, US, FDA Tags: Form 483
A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Keytruda, Merck, biomarkers, oncology approvals
EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: Clinical, Compliance, Government affairs, Research and development, News, Europe, EMA Tags: clinical trial regulations, EMA guideline
Trump’s 2018 Budget Seeks Last-Minute Renegotiation of FDA User Fee Deals

President Donald Trump's FY 2018 budget proposal for the US Food and Drug Administration (FDA), leaked late Monday, seeks a last-minute renegotiation of user fee deals forged over the last two years to make up for about a 30% decrease in the agency’s budget.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA Tags: Trump budget, FY 2018 FDA budget
WHO Elects First African Director-General

The World Health Organization (WHO) on Tuesday announced that Dr. Tedros Adhanom Ghebreyesus of Ethiopia has been elected by member states as the new Director-General of WHO.

Categories: Government affairs, News, Africa, WHO Tags: Director-General WHO
Gottlieb Establishes FDA Committee to Confront Opioid Crisis

Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction."

Categories: Drugs, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: opioids, Scott Gottlieb, Opioid Policy Steering Committee
FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials.

Categories: Active pharmaceutical ingredients, Crisis management, Manufacturing, News, US, China, FDA Tags: FDA warning letters, China API manufacturers
Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, News, Asia, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S
Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA, EC, Health Canada, TGA, WHO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
New Indication for Roche’s Actemra Means First FDA-Approved Drug to Treat Giant Cell Arteritis

The US Food and Drug Administration (FDA) on Monday expanded the approved use of Roche’s Actemra (tocilizumab) to treat adults with giant cell arteritis, making it the first FDA-approved therapy for this condition.

Categories: Biologics and biotechnology, Government affairs, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Actemra, Roche, giant cell arteritis, monoclonal antibodies
Australia Considers Allowing the Marketing of Devices Approved Overseas

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled a plan to further converge its medical device regulations with those from comparable overseas regulators and allow for the use of devices that have received marketing approvals from some foreign authorities.

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, Oceania, TGA Tags: Australia's TGA, medical devices in Australia, conformity assessments, regulation of devices
FDA to Drug Manufacturers: Beware Water-Borne Contaminants

With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose.

Categories: Crisis management, Manufacturing, News, US, FDA Tags: pharmaceutical contamination, FDA on contamination, BCC, water contaminants
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