Drugs
A new study in Clinical Pharmacology & Therapeutics shows that FDA and European Medicines Agency (EMA) reviewers have a “high concordance” (91–98%) in approving/rejecting new drug applications, and that this suggests that “engagement and collaboration on regulatory science has a positive impact.” Conducted by officials from both agencies,
Drugs
FDA has approved a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with narcolepsy. The company says the drug is the first with this indication that is not scheduled as a controlled substance. It says that the selective histamine 3 (H) receptor antagonist/inverse
Devices
FDA and the other members of the Medical Device Innovation Consortium (MDIC) are seeking public comment until 9/13 on the group’s white paper “Best Practices for Communicating Benefit, Risk, and Uncertainty.” An MDIC notice (includes a link to the white paper) says the paper will be part of
Drugs
FDA has granted accelerated approval for Genentech’s Rozlytrek (entrectinib) foe treating adult and adolescent patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. The drug also was approved for treating adults with non-small cell
Drugs
FDA has issued a guidance, Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment, with recommendations for industry use in designing nonclinical bone quality studies to support approval of drugs and biologics intended to treat osteoporosis. The document recommends that sponsors review three agency guidances before starting clinical trials of drugs
Drugs
FDA says that since the demand for immune globulin (IG) products has increased in recent years, despite supply increases, there is an ongoing shortage of IG intravenous and IG subcutaneous products in the U.S. that could affect patient care. An agency statement says that in the setting of increased
Drugs
FDA says Pfizer is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets due to potential microbiological contamination of non-sterile products. An agency statement says the company initiated the recall because the lots may not meet its in-house microbiological specification for the potential presence of Genus pseudomonas
Devices
FDA has granted V-Wave a breakthrough device designation for its interatrial shunt for heart failure (HF). The implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal trial called RELIEVE-HF. The study is enrolling advanced HF patients with preserved or reduced left
Drugs
FDA says it will be making changes to its inactive ingredient database (IID) that provides information on inactive ingredients present in FDA-approved drugs. The information can be used by industry as an aid in developing new drugs, an agency notice says. The notice says FDA will use a phased
Drugs
The New York Times editorial board says that while the goal of getting new medicines to desperate patients as quickly as possible is a worthy one, the uncertainty surrounding expedited drugs has strained the public’s trust and made it easy for insurance companies to deny coverage for such drugs.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910-0131). Such agreements must contain the following: (1) Each firms’ contact information and the identification of the signature authority of the shipper
Drugs
FDA has added three additional questions and answers to the laboratory control section of the questions and answers on current good manufacturing practices guidance. The added questions and answers cover instrument calibration standards for chromatographic systems, system suitability, and trial injections. The agency says that it is essential that analytical
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports an FDA draft guidance on quality considerations for continuous manufacturing and believes the document could benefit from greater clarity on some key concepts. The association’s comment letter also says the guidance’s language could be enhanced to better
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Protection of Human Subjects; Informed Consent; and Institutional Review Boards (IRB) — 21 CFR Parts 50 and 56” (OMB Control Numbers 0910-0755 and 0910-0130). On its own in initiative, the agency is consolidating the information collections
Drugs
FDA has approved the Global Alliance for TB Drug Development’s Pretomanid tablets to be used in combination with bedaquiline and linezolid to treat a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant, or non-responsive multidrug resistant pulmonary tuberculosis. An agency statement says that
Drugs
FDA has issued Dr. Reddy’s Laboratories two complete response letters for generic copies of Teva’s multiple sclerosis drug Copaxone (glatiramer acetate injection) and Merck’s female contraceptive Nuvaring (etonogestrel/ethinyl estradiol) vaginal ring. Dr. Reddy’s declined to disclose the reasons for the FDA rejection letter, but said
Drugs
Federal Register notice of intent: FDA has announced its intention to begin inactivating drug listing records that are improperly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently
Drugs
House Committee on Oversight and Reform chairman Elijah Cummings (D-MD) and Senate Budget Committee ranking member Bernie Sanders (I-VT) have written to three drug companies asking about their pricing of generic drugs and opening an investigation into what Cummings and Sanders say is the companies’ coordinated obstruction of
Devices
FDA has cleared Pollogen’s radiofrequency (RF) home-use device TriPollar Stop for treating the face and the neck to eliminate aging signs, reduce lines and wrinkles and improve skin strength, texture and elasticity. The device uses Pollogen’s triple-axis RF waves to introduce heat to the dermis, which
Drugs
The FDA Oncology Center of Excellence (OCE) and Syapse have signed a multi-year research collaboration agreement focusing on using real-world evidence (RWE) to support regulatory decision making. Syapse says that it and OCE “will work with stakeholders across FDA to address key regulatory questions about testing and treatment
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” The document provides the agency’s current thinking on clinical trial designs and clinical endpoint assessments to support developing such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Child-Resistant Packaging Statements in Drug Product Labeling.” The document discusses the information that should be included to support child-resistant packaging statements in prescription and over-the- counter human drug product labeling. To view the notice, click here.