Devices
A Congressional Budget Office (CBO) cost estimate says that implementation of S. 1622, the FDA Device Accountability Act of 2016, would cost $7 million over the 2017-2021 period, subject to the availability of appropriated funds. The bill would require the agency to train certain employees to determine the least
Drugs
Senate HELP Committee chairman Lamar Alexander (R-TN) says that Senate should finish its work on the 21st Century Cures legislation in September. “Rarely do we have such an opportunity,” Alexander says in a statement. “It includes support for the president’s precision medicine initiative and the vice president’s
Devices
Prisym ID says that too many medical device companies are not aware of or fail to follow FDA regulations on labeling of their products. “The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach
Drugs
Juno Therapeutics has submitted a complete response to FDA to address concerns after a clinical hold was ordered on a Phase 2 clinical trial (ROCKET) involving JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the hold on the trila after three patient
Drugs
FDA has granted Merrimack Pharmaceuticals fast track status for MM-121 (seribantumab) for treating patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Currently, Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with
Drugs
After an unexplained gestation period of nine years, FDA has denied a 7/28/97 Luitpold Pharmaceuticals petition asking the agency to withdraw its approval of the intramuscular route of administration for INFeD, an injectable iron dextran product that at the time of the petition was manufactured by Schein Pharmaceutical.
Drugs
Boehringer Ingelheim says that while the main purpose of an FDA draft guidance on chemistry, manufacturing, and controls information in comparability protocols for human drugs and biologics is well stated in the draft’s introduction and background sections, it loses focus in its content recommendations. The company’s comment letter
Drugs
FDA has granted AbbVie a rare pediatric disease designation for ABT-414, an investigational antibody drug conjugate targeting the epidermal growth factor receptor (EGFR) for treating pediatric patients with EGFR-amplified diffuse intrinsic pontine glioma (DIPG). The highly aggressive and difficult to treat brain tumors are found at the base
Drugs
An FDA statement says that the agency is changing its procedure for inspections of entities that are seeking to compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (human drug compounders not registered with FDA as section 503B outsourcing facilities). As of 8/1, it says,
Devices
FDA has approved the Roche cobas HPV test as the first test for human papilloma virus that can be used with cervical cells obtained for a Pap test and collected in SurePath preservative fluid. An agency statement says that the Roche test is the first to be approved for use
Drugs
An 8th Circuit Court of Appeals panel voted 2-1 to uphold a district court ruling imposing three-month prison sentences and $100,000 fines on the owner and COO of Quality Egg under the Park (responsible corporate officer) doctrine. Attorneys Jennifer Thomas and John Fleder (Hyman, Phelps & McNamara)
Devices
FDA has approved Abbott Vascular’s Absorb GT1 bioresorbable vascular scaffold system, which releases the drug everolimus to limit the growth of scar tissue and is gradually absorbed by the body in about three years. It is the first fully absorbable stent to treat coronary artery disease. An FDA news
Drugs
FDA has approved Galderma Laboratories’ Differin Gel 0.1% (adapalene), a once-daily topical gel for over-the-counter treatment of acne in people age 12 and older. An agency statement says Differin Gel is the first retinoid to be made available OTC for treating acne. FDA also says the
Drugs
FDA says it is supporting President Obama’s Precision Medicine Initiative through release of two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. An agency statement (contains links to both
Drugs
FDA has issued a draft guidance, Updating ANDA Labeling After the Marketing Application for the Reference-Listed Drug Has Been Withdrawn, to describe a process for updating labeling for ANDAs in cases when FDA has withdrawn approval of the NDA for the reference-listed drug (RLD) for reasons other than
Devices
A 1/25-1/28 FDA inspection at Zimmer Biomet Holding’s manufacturing facility in Montreal, Canada, found multiple violations of the agency’s Quality System Regulation in the manufacturing of the iAssist knee system, Zimmer PSI shoulder system, Zimmer PSI knee system, and the Navitrack system. A just-released
Drugs
A 7/20-24/15 FDA inspection at Guangzhou Haishi Biological Technology, Guangzhou, Guangdong, China, found significant violations of current good manufacturing practice for finished pharmaceuticals, according to a just-released 6/22 Warning Letter. Specific violations included: * failing to test finished batches of drug products for the identity and
Drugs
AstraZeneca has filed a motion seeking a temporary restraining order (TRO) to block FDA from approving generic copies of the company’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium) if they are approved with a labeling “carve-out” that omits marketing exclusivity-protected pediatric labeling. The TRO request follows last month’
Drugs
The Federal Circuit Court of Appeals has affirmed a lower court decision granting Amgen a preliminary injunction blocking Apotex from launching its biosimilar pegfilgrastim for 180 days after receiving FDA approval and giving notice of commercial marketing. Apotex had argued that because the two parties completed the Biologics Price Competition
Drugs
The National Cancer Institute (NCI) says it is working with three organizations in England and the Netherlands to develop the Human Cancer Models Initiative that will bring together expertise from around the world to make about 1,000 cancer cell models. “Using new techniques to grow cells, scientists can make
Drugs
Mallinckrodt is asking FDA to designate Inomax (nitric oxide) 800 ppm for inhalation and its 510(k)-cleared specialized delivery system as a drug-device combination product. A 6/30 citizen petition says that Inomax is approved for use in treating neonates greater than 34 weeks gestational age suffering from
Biologics
FDA reviewers say an Amgen BLA (ABP 501) for a proposed biosimilar product referencing AbbVie’s Humira for treating arthritis is highly similar to the innovator product. The agency’s Arthritis Drugs Advisory Committee will review and vote on the submission 7/12. “The comparison of the structural and functional