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
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
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
Drugs
Altaire Pharmaceuticals has recalled numerous brands of over-the-counter eye drops sold at CVS Health due to sterility concerns. A recall notice says that the concerns involve “the sufficiency of quality assurance controls over critical systems in the manufacturing facility.” FDA has determined that the issues indicate a lack
Drugs
Hamilton Medical has recalled its Hamilton-G5 Ventilators due to the potential for “panel connection lost” error messages to be displayed and resulting in the ventilator to stop working and enter an ambient state. “When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator
Drugs
FDA has cleared an Icotec 510(k) for the Vader One pedicle screw system for use in both minimally-invasive and open spine surgical procedures. The device, which is made from Icotec’s BlackArmor carbon/PEEK (polyetheretherketone) material, was designed for “secure stabilization and post-operative visualization, which is important
Drugs
Janssen Pharmaceutical Companies has submitted a BLA for Darzalex (daratumumab) that seeks approval of a new subcutaneous formulation for treating certain patients with multiple myeloma. Currently, Darzalex is approved as an intravenous (IV) treatment. The submission is supported by data from the Phase 3 COLUMBA (MMY3012) study that included a
Drugs
FDA has published a draft guidance, Population Pharmacokinetics, to assist NDA and BLA sponsors to apply population pharmacokinetic (population PK) analysis. The document says population PK is frequently used to guide drug development and inform recommendations on therapeutic individualization, such as through tailored dosing. “Adequate population PK data collection and
Drugs
FDA has issued a draft guidance, Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy, with recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy. The document says that drug product development in hormonal contraception has evolved
Drugs
FDA has accepted for review a Neurocrine Biosciences NDA for opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing off episodes. The agency has set a standard 12-month review with a user fee target
Drugs
The Virginia U.S. Attorney says Reckitt Benckiser has agreed to pay $1.4 billion to resolve potential civil and criminal liability relating to marketing of its opioid addiction treatment drug Suboxone. A news release says the resolution is the largest recovery by the federal government in an opioid drug
Drugs
FDA says it has completed “capability assessments” of the 28 European Union (EU) member states under the FDA/EU Mutual Recognition Agreement (MRA). The completed assessments allow FDA to rely on the drug inspections conducted by these foreign regulatory authorities. The 28 regulatory authorities found to be capable are those
Drugs
FDA has published a draft guidance, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process, to assist applicants and drug master file holders to start either revisions to an existing monograph(s) or development of a new monograph(s) during the agency’s evaluation of a
Drugs
Medical Research Collaborative is petitioning FDA to have an Amarin Corp. patent removed from the Orange Book for being improperly listed. The 7/8 petition says the Amarin patent for highly purified ethyl EPA and other EPA derivatives “does not claim an approved method of using the drug, promotes unapproved
Drugs
Reacting to a federal judge’s ruling that HHS lacks statutory authority to require publication of drug list prices in certain direct-to-consumer drug ads, Senate Finance Committee chairman Chuck Grassley (R-IA) says he and Sen. Dick Durbin (D-IL) will continue to fight to have the prices
Drugs
The HHS Office of Inspector General (OIG) says progress has been made in decreasing opioid use in Medicare Part D and increasing use of medication-assisted treatment for opioid use disorder. The OIG report says it is “imperative for HHS, including the Centers for Medicare and Medicaid Services, to continue
Drugs
U.S. WorldMeds, which holds an NDA for Apokyn (apomorphine hydrochloride injection) indicated for acute, intermittent treatment of some aspects of Parkinson’s disease, says FDA should require that any ANDA for a generic version of Apokyn seek approval of both its drug and device constituent parts. The company says
Drugs
Four K&L Gates attorneys dissect two Justice Department policy statements and their impact on healthcare companies and their law firms in an online blog post. The attorneys first examine a 1/2018 memo issued by Civil Fraud Division director Michael Granston to determine what has happened over the
Drugs
FDA has released the FDA-483 issued following a 6/13-6/21 inspection at the Dr. Reddy’s drug manufacturing facility in Andhra Pradesh, India. Specific inspection observations were: * failing to establish acceptance activities prior to performance of validation activities; and * failing to correctly translate device design into production
Drugs
A CDER Manual of Policies and Procedures gives the policies and procedures for staff in the Office of New Drugs, Office of Generic Drugs, and other CDER offices when implementing the law on requirements for safety labeling changes for approved drugs under the FDA Amendments Act of 2007 (FDAAA). The