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.

Regulatory Recon: Indian Drug Regulator Called a 'Snake Pit of Vested Interests (23 July 2014)

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
Regulatory Recon: Should FDA Guidance on Mobile Apps be Made Permanent? (22 July 2014)

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
Nuclear Regulators Ease Burden on Some Medical Devices, Expediting New Trials

Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC).

Categories: In vitro diagnostics, Medical Devices, News, US Tags: NRC, Nuclear Regulatory Commission, Radioactive, SSRD, Sealed Source and Device Registry, Byproduct Material
FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs

The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.

Categories: Generic drugs, Clinical, News, US, CDER Tags: BE, Bioequivalence, Bioequivalence Standards
Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in Warning Letter

Pharmaceutical compounders, take note: The US Food and Drug Administration (FDA) wants you to stop using laminated particleboard in your aseptic processing areas.

Categories: Drugs, Compliance, Quality, News, US, CDER Tags: Pharmaceutical Compounding, Compounding, Sterile Compounding, ISO 5, Cleanroom, Asceptic, Aseptic, Particleboard, Warning Letter
Public Comment Period Opens on ISO 9001, Major Device Quality Standard

The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation.

Categories: In vitro diagnostics, Medical Devices, Manufacturing, Quality, News, ISO Tags: ISO 9001, QMS, Quality Management System, Consultation, International Standards Organization, ISO
Regulatory Recon: UK Unveiling Device Safety Changes (21 July 2014)

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
Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media.

Categories: Prescription drugs, Labeling, News, US, CDER Tags: OPDP, Untitled Letter, Advertising, Marketing, Promotion, Phone Script, One-Click Rule,
ONC Director Defends Health IT Safety Center as it Struggles to Take Shape

In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not—have.

Categories: In vitro diagnostics, Medical Devices, News, US, FDA Tags: ONC, FDA, FDASIA, Health IT, Health IT Safety Center, Karen DeSalvo, House, Legislators, Energy & Commerce Committee
After 'Arduous' Setbacks, FDA's Generic Drug Strategy Takes Shape in New Leadership

The US Food and Drug Administration's (FDA) long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today.

Categories: Generic drugs, News, US, CDER Tags: OGD, Office of Generic Drugs, Janet Woodcock, ORS, OB, OGDP, ORO, Super Office
With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines.

Categories: Biologics and biotechnology, News, US, CBER Tags: VAERS, Vaccine, ESG, Electronic Submission Gateway, ICSR
Ireland Considers Switching 12 Medicines to OTC Status

Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC).

Categories: Over the counter drugs, News, Europe Tags: Ireland, OTC, Over-the-Counter, Rx-to-OTC Switch
Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out

How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising.

Categories: Drugs, News, US, CDER Tags: Study, DTC Advertising, Teenagers, Young Adults, Adolescents
Regulatory Recon: FDA's India Office Loses Leader (18 July 2014)

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
Spain Launches new Registry of API Manufacturers, Distributors, Importers

The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain.

Categories: Active pharmaceutical ingredients, Submission and registration, News, Europe Tags: Spain, API, Active Pharmaceutical Ingredient, AEMPS, Registration
House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group.

Categories: Generic drugs, News, US, CDER Tags: Generic Drug, ANDA, CBE-0, Generic Drug Labeling Rule, House, Legislators
FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola—the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month.

Categories: Biologics and biotechnology, Crisis management, News, US, CBER Tags: Smallpox, Variola, Q Fever, Dengue, Influenza, Rickettsia, Cold Storage
Regulatory Recon: FDA Won't Place Serious Warning on Testosterone Products (17 July 2014)

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 Wants to Make Product Recalls Easier to Track

A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Product withdrawl and retirement, News, US, FDA Tags: openFDA, Application programming Interface, API, Recalls
FDA to Spend up to $10 Million Strengthening Regulation in South America

US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region.

Categories: News, US, Latin America and Caribbean, FDA Tags: PAHO, Pan American Health Organization, Cooperative Agreement, Award, Regulatory Capacity
Head of FDA's Rare Disease Division Departs, Leaving Agency Looking for New Leader

The US Food and Drug Administration (FDA) is looking for a new leader for its Rare Diseases Program.

Categories: Biologics and biotechnology, Drugs, News, US, CDER Tags: Office of New Drugs, OND, Rare Disease Program, Rare Disease, Anne Pariser, Larry Bauer
India’s CDSCO Sets up Whistleblower Reward Scheme

India’s Central Drugs Standard Control Organisation  (CDSCO) has set up a scheme for providing monetary rewards to informers who provide specific information leading to the seizures of spurious, adulterated, misbranded and not-of-standard-quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers and CDSCO officers involved.

Categories: Drugs, Medical Devices, Ethics, News, India, CDSCO Tags: Whistleblower, DCGI, MHFW, Informants
FDA Tries to Invigorate Development of Therapies for 'Neglected' Tropical Diseases

New guidance released earlier this month by the US Food and Drug Administration (FDA) aims to make it easier for some companies to develop products for so-called "neglected" tropical diseases (NTDs) affecting the developing world.

Categories: Biologics and biotechnology, Drugs, Clinical, Research and development, News, US, FDA Tags: NTDs, Neglected Tropical Disease, Guidance, Tropical Disease Priority Review Voucher
What's the Best Time to Submit a 510(k) Application to FDA?

What if there was a particular month when your submission would be cleared faster than any other month? Wouldn’t it be great to know that your submission is going into the US Food and Drug Administration (FDA) at the optimal time?

Categories: In vitro diagnostics, Medical Devices, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: 510(k), 510(k) Filing, Best Time to Submit 510(k), 510(k) Filing Strategy, 510(k) Review Times, RIQ, Regulatory Intelligence Quotient
Three Years After Warnings, FDA Bans Last High-Dose Aceptaminophen Products

All prescription drugs containing high doses of acetaminophen have officially been withdrawn from the market, the US Food and Drug Administration (FDA) indicated in a regulatory filing this morning.

Categories: Drugs, Product withdrawl and retirement, News, US, CDER Tags: Acetaminophen, Withdrawal, Removal, 325 mg Acetaminophen
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