Biologics
A 2/13-2/25 FDA inspection at the Virginia Center for Reproductive Medicine, Reston, VA, identified significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 7/1 Warning Letter says specific deviations were: * failing to test a specimen from an anonymous or
Drugs
A 1/28-2/5 FDA inspection at the Strides Pharma Science drug manufacturing facility in Puducherry, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 7/1 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility
Drugs
An FDA Center of Excellence in Regulatory Science and Innovation (CERSI) research study conducted with Yale University and the Mayo Clinic will use the Biofourmis BiovitalsHF mobile platform, starting with a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Focus Groups About Drug Products as Used by the Food and Drug Administration” (OMB Control Number 0910-0677). The agency says focus groups are intended to provide a more in-depth understanding of individuals’ attitudes, beliefs, motivations,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0827). Outsourcing facilities must register with and submit regular reports identifying the
Drugs
FDA has posted a draft guidance as its seventh revision to “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission
Devices
FDA has issued a safety alert about potential complications in patients implanted with both programmable cerebrospinal fluid (CSF) shunt systems and some hearing implants that contain magnets, such as cochlear implants, bone conduction hearing devices, or middle ear hearing devices. “Magnetic interactions between these devices may occur when implanted in
Drugs
An 8/17-9/7/18 FDA inspection at the Ecometics drug manufacturing facility in Norwalk, CT, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/16 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures
Drugs
Rep. Mike Kelly (R-PA), a diabetic and member of the Congressional Diabetes Caucus, is asking FDA for information on issues that may have contributed to it not listing insulin as a peptide drug product eligible for generic production in ANDA guidance issued 10/2017. In a 7/16 letter
Drugs
Amgen says an FDA draft guidance on adjusting for covariates in randomized clinical trials for drugs and biologics with continuous outcomes is easy to read and concise. In a comment letter, the company says it would be useful to add recommendations on how stratification variables should be handled, more detailed
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ecometics, Norwalk, CT (4/16): FDA inspected the firm’s drug manufacturing facility 9/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
Drugs
FDA has published the International Conference on Harmonization E9 guideline, Optimization of Safety Data Collection. The document says it is intended to provide internationally harmonized guidance on an optimized approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a
Biologics
FDA has accepted for priority review a Novartis BLA for its investigational sickle cell drug crizanlizumab. The submission seeks approval for preventing vaso-occlusive crises (VOCs) in patients with sickle cell disease. Novartis says that VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic
Devices
Stakeholders say they support an FDA proposal to reclassify internal surgical staplers as Class 2 devices and to implement uniform special controls as part of the reclassification. In a letter commenting on an agency draft guidance, Medtronic says that conducting additional bench and animal testing on devices that have been
Drugs
FDA has approved Teva Pharmaceutical Industries’ AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. The product is indicated for treating
Devices
FDA has announced two “innovation challenges” to encourage the development of new approaches to device sterilization. They are: Challenge 1: To identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide. Challenge 2: To develop strategies or technologies to reduce emissions to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Hypertension Indication: Drug Labeling For Cardiovascular Outcome Claims” (OMB Control Number 0910-0670). The collection encourages the submission of supplemental labeling and is intended to assist applicants in developing labeling for outcome
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ NDA for Miochol (acetylcholine chloride intraocular solution), 20 mg/vial, was not withdrawn from sale due to safety or effectiveness issues. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met.
Drugs
FDA tends to be more restrictive than its advisory committees when approving new products, new supplemental indications and new safety changes, according to New York University School of Medicine and Yale School of Medicines writing in Milbank Quarterly. A new study has examined advisory committee meetings where FDA and panel
Drugs
FDA has issued AstraZeneca a complete response letter on a supplemental NDA for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycemic control in adult patients with Type-1 diabetes, when insulin alone does not provide adequate control. The drug was recently approved in Europe and Japan for
Devices
FDA has cleared a LivaNova 510(k) for its LifeSPARC system, a new circulatory support pump and controller, intended for use in providing temporary support for emergent rescue patients in a variety of settings. The device includes four specialized and ready-to-deploy kits, each designed to support diverse cannulation
Devices
FDA has approved an Abbott PMA for its fourth-generation MitraClip, a heart valve repair device to treat mitral regurgitation. The latest version includes an expanded range of clip sizes, an alternative leaflet grasping feature and real-time procedure assessment to offer doctors further options when treating mitral valve disease,