FDA Pharmaceutical and Medical Device Headline News

An 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

The 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

Drugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status.Read More

The 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

Clinical 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

An 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 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

Three 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

The 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

A global treaty is needed to galvanize the necessary resources to combat elusive criminal networks counterfeiting drugs.Read More

Sonic 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

Devicemakers 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

Trial 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

As 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

NDA 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

Sen. 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

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 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

An 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

CINCINNATI — 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

The 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

A 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

Congress 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’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

CINCINNATI — 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

Concerns 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

The House has updated its draft of omnibus FDA user fee legislation with much-anticipated language on supply chain safety.Read More

Members 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

Citing 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

Federal 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

Cross-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

Ongoing 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’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

An 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

Lax 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