Drugs
FDA commissioner Scott Gottlieb told a House FDA Appropriations Subcommittee hearing 5/25 that the Trump Administration’s January-ordered hiring freeze at FDA has been lifted and the agency is expediting the addition of new hires. “In getting the hiring freeze lifted so quickly, Dr. Gottlieb and his team
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by the Office of Management and Budget. Collections approved included Importer’s Entry Notice; Postmarket Surveillance of Medical Devices; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications; Animation in Direct-to-Consumer
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).” FDA regulation authorizes it to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions. It also requires user facilities to report device-related
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection “Application for FDA Approval To Market a New Drug.” This notice solicits comments on the requirements governing marketing applications for new drugs. To view the notice, click here.
Drugs
FDA has completed three inspections this month at contract research organization BioPharma Services, and it did not issue any Form 483s. Concurrent inspections occurred at both research centers in Toronto, Canada, and Columbia, MO, according to the company, which added that an additional inspection was conducted at the Columbia facility
Drugs
FDA has sent a complete response letter to Sun Pharma for its NDA for Elepsia XR (levetiracetam) extended-release tablets 1,000 mg and 1,500 mg. A company disclosure letter to the National Stock Exchange of India says the FDA letter references the agency’s recent inspection at the
Drugs
An FDA Small Business and Industry Assistance podcast gives instructions for complying with the requirement to file master files and associated documents in the electronic Common Technical Document (eCTD) format. Deadline for using the format has been extended from 5/5/17 to 5/5/18 to give companies an
Drugs
Some 65 members of the House of Representatives from both parties are urging FDA to rescind its decision restricting state-licensed pharmacies from compounding prescription drugs for healthcare providers to use in their offices. The move is being led by Reps. Chris Stewart (R-UT) and Earl Carter (R-GA)
Drugs
The FDA Oncologic Drugs Advisory Committee has voted 10-3 to recommend that the overall risk/benefit profile of Emmaus Life Science’s Endari for treating sickle cell disease is favorable. The agency has a PDUFA target date of 7/7 to act on the company’s NDA. If approved,
FDA Policy/General
House FDA budget lawmakers 5/25 dismissed the Trump Administration’s request (see earlier story) to renegotiate user fee agreements to increase the fees by $1.2 billion to offset budget authority decreases. Fresh on the job after two weeks, FDA commissioner Scott Gottlieb represented the agency at a House
Drugs
FDA has granted Abeona Therapeutics an Orphan Drug Designation for its EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa, including recessive dystrophic epidermolysis bullosa (RDEB), which are life-threatening genetic skin disorders characterized by skin blisters and erosions that cover the body. In a Phase 1/2
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. Collections approved include Biological Products: Reporting of Biological Product Deviations and Human Cells; Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum, 3486A; Designation
Devices
FDA has cleared a Bio-Rad Laboratories 510(k) for “enhanced capability” with its IH-Com data management software to manage patient results with the company’s IH-1000 automated blood typing instrument. IH-Com is a data management tool that “combines all current and prior results associated with a
Drugs
Researchers say the FDA accelerated approval process has had generally positive results in speeding new drugs to patients, but it also has created financial issues for public insurers. Writing in a New England Journal of Medicine Perspective column, Walid Gellad and Arnold Kesselheim say that “at a time when medications
Devices
A New Jersey federal judge has dismissed a state product liability suit against Boston Scientific, Guidant, and two related medical device companies because the state law claims are preempted by federal law. Attorney Elizabeth Boggia (Weil Gotshal & Manges) writes in an online blog post that the plaintiff filed suit
Drugs
Attorney James Beck (Reed Smith) says that based on FDA commissioner Scott Gottlieb’s previous agency and non-agency statements, he doubts “that FDA’s absolutist ban on truthful industry speech about off-label uses will continue much longer in its current form.” Writing in an online blog post, Beck
Drugs
Otsuka Pharmaceutical and Proteus Digital Health have resubmitted an NDA for a drug-device combination product using Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The companies are expecting a user fee review action in the fourth quarter. In 4/2016, FDA issued a complete response
Drugs
McNeil-PPC has reached a settlement with 43 state attorneys general to resolve allegations that the company distributed contaminated over-the-counter drugs and unlawfully promoted its products. Pennsylvania attorney general Josh Shapiro announced (includes link to settlement text) that the settlement would bring $1.4 million to his office
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer TV ad for Orexigen’s Contrave (naltrexone HCl and bupropion HCl) extended-release tablets makes false or misleading representations about the risks associated with the drug. “This violation is concerning from a public health perspective because it
Drugs
The Association of Clinical Research Organizations has issued a policy statement detailing its opposition to legislation that would give terminally ill patients access to unapproved treatments, known as “right-to-try” bills. “As the organization representing the world’s leading clinical research organizations that each year conduct more than 7,
FDA Policy/General
Manhattan Research says that just 27% of doctors surveyed find drug company Web sites to be credible sources of professional information. Doctors value useful drug company content that helps them do their jobs better such as quality scientific information, patient education, and diagnostic tools, the firm’s Taking the Pulse
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “FDA Advisory Committee Membership Nominations — OMB Control Number 0910.” Comments are requested on the FDA Advisory Committee Membership Application for accepting nominations of technically qualified experts. To view the notice, click here.