FDA Pharmaceutical and Medical Device Headline NewsMDUFA Moves to House Floor, Decision Summaries for Some 510(k)s LikelyAn omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices.Read More
Developed, Developing Nations Should Work in Tandem to Ensure Safe ImportsThe U.S. Food and Drug Administration (FDA) and other agencies must provide expertise, training and tools to developing nations to improve their device and drug monitoring practices and prevent dangerous healthcare products from entering the U.S., according to an April 4 Institute of Medicine (IOM) report. Read More
Expert: Don’t Expect Guidance on Biosimilar Interchangeability Anytime SoonDrugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status.Read More
MHRA’s New Falsified Medicines Strategy Takes Aim at InternetThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled a new anti-counterfeiting strategy that builds off a 2007 strategy with increased international collaborations to fight the expanding risk of fake drugs online.Read More
Too Many Small Studies Among Flaws Seen in U.S. Trials EnterpriseClinical trial stakeholders must look for opportunities to join forces on larger, more meaningful studies to boost trial efficiency, a Duke University researcher says.Read More
Stricter Investigator Disqualification Standards Go Into Effect This MonthAn FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.Read More
Bulgaria to Create Electronic Register to Increase Medtech TransparencyBulgaria is creating an electronic register of medical devices to promote transparency and increase its control over device procurement, according to PMR, a British-American company providing information to international businesses interested in Central and Eastern Europe.Read More
Senators Urge FDA to End Generic Labeling PreemptionThree Senators are urging the FDA to end generic labeling preemption and allow generic-drug makers to make safety changes to product labeling even if it will no longer mirror the brand-drug label. Read More
MHRA Criticizes EU Drug Verification Plan as CostlyThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is taking issue with an EU plan to scan all drugs at the point of dispensing, saying the cost of providing scanners at all healthcare outlets is too burdensome.Read More
U.S.-Led Global Treaty Needed to Nix Counterfeit Drugs, Scholar SaysA global treaty is needed to galvanize the necessary resources to combat elusive criminal networks counterfeiting drugs.Read More
Hearing Aid Maker Says 483 Prompted New Mindset on MDRsSonic Innovations is taking a more conservative view of FDA regulations on reportable events after getting an FDA Form 483 for lapses in complaint handling and reporting procedures.Read More
Watch Your Words in Social Media LandscapeDevicemakers wishing to establish a full online presence must take special care to ensure their use of social media doesn’t throw them out of compliance with FDA promotional speech regulations, Edward Basile, from consulting firm King & Spalding, told a recent session of the FDA/Xavier University MedCon. Read More
Serious or Not, Notify FDA of All Trial Safety Events, Guidance StatesTrial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to new guidance.Read More
Adverse Event Reporting: A Global Look From Pre- to PostmarketAs fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry. Read More
Supplements Have Seen More Regulatory Burdens Than Standard Filings, Tufts FindsNDA and BLA supplements have created more headaches for pharma companies than standard new drug or biologic applications, finds a new study from the Tufts Center for the Study of Drug Development.Read More
U.S. Lawmaker Takes Drugs Chief to Task for Not Doing More on Drug ShortagesSen. Richard Blumenthal (D-Conn.) March 29 called the U.S. Food and Drug Administration’s (FDA) response to drug shortages “inadequate,” saying lawmakers need to give the agency more tools and mandates to correct the issue. Read More
FDA Prodded to Push Bio-Innovation; Agency Eyes ‘Science Enclaves’To boost biopharma innovation and U.S. competition in the sector, the FDA should incentivize precompetitive industry collaborations, promote public-private partnerships and wrap up integration of its information technology (IT) systems, a new Obama administration paper states. Read More
China to Amend Device Regs This Year, New GMP Compliance Rules AnticipatedChina is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.Read More
Stricter Investigator Disqualification Standards Go Into Effect This MonthAn FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.Read More
Reconstructing 510(k) Decisions Key to New GuidanceCINCINNATI — Fears over a draft guidance on submitting 510(k)s for product alterations may be overblown, but industry and regulatory experts agree it changes the status quo.Read More
House Subcommittee Passes PDUFA, Full Committee Votes Later This WeekThe House Energy and Commerce Committee will vote on an omnibus FDA user fee bill today as lawmakers hurry to move it toward enaction well before the current iteration of the Prescription Drug User Fee Act (PDUFA) expires on Sept. 30.Read More
MHRA to Streamline OTC Reclassifications, Improve Communications With SponsorsA Medicines and Healthcare products Regulatory Agency work group is developing proposals for streamlining the UK’s over-the-counter drug reclassification process, and plans to release updated guidance on the subject later this year, according to an MHRA report.Read More
U.S. Lawmakers Asked to Better Monitor, Protect Overseas PatentsCongress and the U.S. Trade Representative need to do more to protect American biopharma patents abroad, an intellectual property (IP) expert tells Congress. Read More
Singapore Eases Registration of Lower-Risk Medical DevicesSingapore’s Health Sciences Authority is easing the registration process and reducing fees for about 70 percent of medical devices, in a bow to industry concerns about the cost of registering devices there.Read More
Innovation Pathway Advances May Be Expanded Throughout AgencyCINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout CDRH, center Director Jeffrey Shuren said Wednesday at the FDA/Xavier University MedCon Conference here.Read More
India: Power Vacuum at CDSCO Blamed for Slowdown in Device Import LicensesConcerns over who will take over as the Drug Controller General of India (DCGI) in mid-May are leading some industry observers to worry about another backlog in medical device import licenses and registrations.Read More
Updated House User Fee Draft Highlights Lack of Consensus on Track-and-Trace SystemThe House has updated its draft of omnibus FDA user fee legislation with much-anticipated language on supply chain safety.Read More
East African Nations to Harmonize Drug Registration ProcessesMembers of the East African Community (EAC) and public and private international aid organizations March 30 launched an initiative to promote harmonization of drug registration in Kenya, Uganda, Tanzania, Rwanda and Burundi.Read More
CBER Launches Vaccine Oversight Program to Address Global BoomCiting a global surge in the use of vaccines, CBER is launching a new initiative to ramp up global pre- and postmarket vaccine pharmacovigilance.Read More
Feds Nab 11 Linked To Cargo Thefts at Lilly, GSK and OthersFederal authorities have arrested 11 South Florida men in connection to multi-million dollar drug thefts at the warehouses of Eli Lilly in Connecticut, GlaxoSmithKline (GSK) in Virginia and others.Read More
GHTF Proposes Risk-Based Tool for Harmonizing Device AuditsCross-border sharing of devicemaker audit results should be easier, thanks to a standardized nonconformity grading system developed by the Global Harmonization Task Force’s (GHTF) Study Group 3.Read More
Rocky Mount Mending, But GMP ‘Issues’ Persist: Hospira CEOOngoing remediation at Hospira’s Rocky Mount, N.C., plant is on track with the aid of new hires and consultants, the company says. Read More
Singapore, Malaysia Agree to Joint Inspections, Information ExchangeSingapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Board (NPCB) will exchange drug registration assessment reports and conduct joint inspections of manufacturing plants under a March 27 memorandum of understanding.Read More
Beefed-Up Rule on Investigator Disqualification Takes Effect This MonthAn FDA final rule with stronger restrictions on the work of disqualified trial investigators will take effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.Read More
Lung Assist Maker Warned on Lacking DocumentationLax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device have earned the German company an FDA warning letter. Read More
|