Devices
FDA has cleared a NeoTract 510(k) for new indications for the UroLift System to treat an enlarged prostate or benign prostatic hyperplasia. The expanded indications cover patients who have an obstructive median lobe and those as young as 45 years of age. Previously, the device was contraindicated in patients
Devices
FDA has cleared a Corindus Vascular Robotics 510(k) for the CorPath GRX System and its use in peripheral vascular interventions. The CorPath System is the only medical device to bring robotic precision to both percutaneous coronary intervention and peripheral vascular intervention procedures, the company says. During procedures, interventional cardiologists
Drugs
FDA says Divinity Products Distribution, Grain Valley, MS, has destroyed and recalled a large volume of kratom-containing dietary supplements it manufactured and distributed nationwide under three brand names. An agency news release says the company also agreed to stop selling all products containing kratom. “Based on the scientific evidence
Drugs
BIO says FDA should expand a draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease to provide further thinking on the agency’s receptivity to innovative approaches for developing targeted therapies. In its comment, BIO also recommends the draft guidance reflect a scenario in which
Drugs
FDA has sent a second complete response letter to Apricus Biosciences on its NDA for Vitaros (alprostadil topical cream) for treating erectile dysfunction. The company says the letter indicates that the agency cannot approve the submission in its present form, identifying deficiencies related to chemistry, manufacturing and controls and certain
Drugs
FDA has accepted for review an Acorda Therapeutics NDA for Inbrija (inhaled levodopa) for treating symptoms of Off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The agency has set a user fee review action target date of 10/5. The submission includes data from a
FDA Policy/General
Federal Register final rule: FDA has amended its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S. to support a device submission to require that such studies be conducted in accordance with good clinical practice. This includes obtaining and documenting the review and approval
Drugs
Pfizer and several other stakeholders are asking FDA to provide more detail on how it will incorporate patient experience into regulatory decisions such as benefit/risk considerations. “For example,” Pfizer says in a comment letter on an agency patient-focused drug development (PFDD) discussion document, “it would be helpful to
Drugs
FDA has issued two documents relating to bioresearch monitoring. A draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions, describes the electronic submission of certain data and information in standardized formats, and supersedes a previous draft guidance.
Drugs
The DC federal court says FDA has given an adequate rationale for granting pediatric exclusivity to Johnson & Johnson’s Ortho Tri-Cyclen (ethinyl estradiol and norgestimate) but denying it for Amgen’s Sensipar (cinacalcet hydrochloride). Amgen had sued FDA over the agency’s decision not to grant Sensipar pediatric
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Collegium Pharmaceutical exhibit booth for its Xtampza ER (oxycodone) extended-release capsules for oral use made false or misleading representations because it failed to adequately communicate information about the serious risks associated with the drug’s use. A 2/9
Drugs
A law firm that has been litigating cases against Forest Pharmaceuticals related to its off-label promotion of the antidepressant Celexa (citalopram) for use in children and adolescents says Forest lied to FDA and the U.S. Attorney’s Office and settlements with the company should be reopened. “Documents and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Casmara Cosmetics, S.A. Valencia, Spain (2/12): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have,
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on issuing and overseeing clinical holds of investigational new drug (IND) applications. The MAPP says that because the regulations specify that an IND goes into effect 30 days after it is received by FDA unless the agency imposes a clinical
Devices
A 2/20-2/22/17 FDA inspection at Pacific Hospital Supply, Miaoli, Taiwan, found Quality System Regulation violations in the firm’s manufacturing of disposable medical supplies including catheters, cannulae, tubing, and aspirators. A just-released 5/26/17 Warning Letter says violations noted on an FDA-483 were:
Drugs
A 5/29-5/31/17 FDA inspection at Casmara Cosmetics, a Valencia, Spain, drug manufacturing company, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/12 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Genmab’s Darzalex (daratumumab) is 1,939 days. Of this time, 1,808 days occurred during the testing phase and 131 days during the approval phase. Darzalex is indicated for treating patients with multiple
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Eli Lilly’s Portrazza (necitumumab) is 2,533 days. Of this time, 2,175 days occurred during the testing phase and 358 days during the approval phase. Portrazza is indicated, in combination with gemcitabine
FDA Policy/General
Federal Register notice: FDA has announced that its Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, and Office of Regulatory Science have been restructured 6/2016 under its Program Alignment Initiative. The reorganization centralized and streamlined laboratory operations, scientific research, and support functions into the Office of
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Export of Food and Drug Administration-Regulated Products: Export Certificate” (OMB Control Number 0910-0498. To view the notice, click here.
Devices
FDA will publish 2/21 an amendment to its regulations on accepting data from clinical investigations for medical devices. The agency says the change will require that data submitted from clinical investigations held outside the U.S. intended to support an IDE, 510(k), request for de novo classification, PMA,
Drugs
The DC federal court has denied a Ferring Pharmaceuticals motion asking the court to enforce an earlier grant of summary judgment to Ferring that remanded to FDA the case of Ferring’s request for five-year exclusivity for its Prepopik colonoscopy preparation solution. The case revolves around a shifting determination