Drugs
FDA has published a final guidance on “Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Result From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” The document discusses the evidence necessary to demonstrate the effectiveness of investigational new drugs or new drug uses intended
Drugs
FDA has issued Roche Molecular Systems an emergency use authorization (EUA) for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-19). The EUA was granted within 24 hours after receiving the application from the company, an FDA release says. “To expedite access to this test, FDA did not
Drugs
FDA has released the FDA-483 issued following a 12/2-12/20/19 inspection at Fusion IV Pharmaceuticals (Axia Pharmaceutical), a Los Angeles, CA, producer of sterile drug products. The inspection observations were: * failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in
Drugs
FDA has finalized a guidance on “Competitive Generic Therapies” which describes the process that generic drug applicants should follow to request designation of such a drug and the criteria for that designation. The document provides information on actions the agency may take to expedite ANDA development and review for drugs
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on criteria for developing and publishing digital content on the FDA Drugs external Web site. The MAPP also sets standards for ensuring that the Drugs Web site is periodically reviewed for currency, accuracy, and consistency with agency and department policies.
Drugs
B. Braun Medical is petitioning FDA to assign AP therapeutic equivalence (TE) ratings to the listings for specified company products in the Orange Book. The petition says the drug products currently have no TE rating assigned. All of the products for which the company seeks an AP rating are considered
Drugs
FDA is alerting healthcare providers and patients to the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). An agency notice says it is aware of infections caused by enteropathogenic Escherichia coli and Shigatoxin-producing Escherichia coli that have occurred following investigational
Drugs
FDA has granted Boehringer Ingelheim and Eli Lilly a fast track designation for Jardiance (empagliflozin) and its use to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease. An ongoing clinical study (EMPA-KIDNEY) is evaluating the effect of Jardiance on kidney disease
Drugs
FDA has released the FDA-483 issued following a 1/20-1/24 inspection at Biocon Limited, an active pharmaceutical ingredient manufacturer in Karnataka, India. The five inspection observations on the form were: * failing to adequately perform cleaning validation protocols designed to assess potential product-to-product carryover in non-
Drugs
FDA has released the FDA-483 issued following a 2/19-2/28 inspection at Maitland Labs of Central Florida, an Orlando, FL, 503B outsourcing facility. The seven inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions; * failing
Drugs
The Biotechnology Innovation Organization (BIO) says FDA should withdraw its proposed rule to allow the importation of some drugs from Canada “in recognition of the safety and cost hurdles” outlined in the association’s comments on the proposal. The BIO letter says that importation is unlikely to materially affect the
Drugs
For a second time, FDA has rejected an Intarcia Therapeutics implant intended to treat Type 2 diabetes by providing a steady supply of reformulated exenatide to diabetes patients. The agency sent the company a complete response letter, according to the Endpoints online newsletter. The company said it was “extremely disappointed
Drugs
FDA has granted accelerated approval to the combination of Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with hepatocellular carcinoma who have been previously treated with sorafenib (Bayer’s Nexavar). An FDA announcement says the efficacy of the combination was investigated in cohort 4 of the CHECKMATE-
Drugs
FDA has published an International Conference on Harmonization (ICH) guidance, Q3D(R1) Elemental Impurities, addressing (1) the evaluation of toxicity data for potential elemental impurities; (2) the establishment of a permitted daily exposure (PDE) for each element of toxicological concern, and (3) the application of a risk-based approach to
Drugs
FDA has issued a draft guidance, Providing Regulatory Submissions in Alternate Electronic Format, with recommendations for submissions covered under an exemption from or a waiver of the requirements addressing the format of content in NDAs, ANDAs, certain drug master files, BLAs, and certain INDs submitted to CDER or CBER. The
FDA Policy/General
FDA has postponed foreign inspection of regulated products until May due to the coronavirus outbreak. “Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis,” FDA commissioner Stephen Hahn says in a release. The State Department has also issued travel restrictions and
Drugs
A 7/29-8/2/19 FDA inspection at Guangzhou Tinci Materials Technology Co., Guangzhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 1/23 Warning Letter says the specific violations were: * failing to use equipment in the manufacture, processing, packing,
Drugs
AnaBios and FDA have reached a research collaboration agreement to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function. Under the agreement, CDER and AnaBios will evaluate “functional human primary cardiomyocytes as standards for reference of gene expression, localization of functional
Drugs
Laying out opposition to an FDA proposed rule on the importation of prescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says “importation is not the solution to lowering patient costs. PhRMA supports fundamental policy changes to achieve solutions that will help patients and produce better and more efficient care.
Drugs
A bipartisan group of 41 members of the House and Senate are asking FDA commissioner Stephen Hahn to deliver on his commitment to improving the clinical trial process for those with terminal illnesses such as amyotrophic lateral sclerosis (ALS). “Our constituents diagnosed with ALS are eager to see action in
Drugs
FDA commissioner Stephen Hahn said at a White House briefing Saturday (3/7) that 1.1 million more coronavirus tests have just been shipped by “nonpublic health labs.” The Trump administration has been struggling to get a handle on test distribution while the virus outbreak continues to grow and deaths
Drugs
FDA has released a final report from an agency-contracted sampling of talc-containing cosmetic products for the presence of asbestos. The testing was performed by AMA Analytical Services. The results showed that 43 samples were negative while nine were positive. “In the case of the positive samples, when the