Drugs
Drug companies are making significant use of artificial intelligence (AI) in drug development, and use of AI is expected to grow as companies seek novel approaches to drug development and encounter growing competition in various disease areas. That’s the major takeaway from a Tufts Center for the Study of
Drugs
FDA has released the FDA-483 issued following a 4/8-4/16 inspection at Torrent Pharmaceuticals, Indrad, Gujarat, India. The four inspection observations on the form were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
FDA has approved Pfizer subsidiary FoldRx’s NDAs for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for treating heart disease caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. An FDA release says these are the first FDA-approved treatments for ATTR-CM. “Vyndaqel and Vyndamax have the same active
Drugs
FDA has made available a final guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document provides an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA about potential or planned medical device IDEs, PMAs, BLAs,
Drugs
Vivimed Life Sciences has recalled 19 lots of losartan potassium tablets USP 25 mg, 50 mg, and 100 mg due to the detection of a known carcinogen — N-nitroso-N-methyl-4-aminobutyric acid (NMBA) — that is above FDA’s interim acceptable exposure limit of 9.82 ppm. The product
Drugs
Par Pharmaceutical has recalled one lot of mycophenolate mofetil for injection after one product vial was observed containing a glass fragment after reconstitution. “The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material,” a recall
Drugs
FDA has released a draft guidance entitled Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for Treatment that provides general recommendations to companies developing such drugs. The document explains that, because ADHD is a disorder that begins in childhood, a new drug application for any drug intended to treat ADHD
Drugs
CDER director Janet Woodcock told the Food and Drug Law Institute’s annual meeting in Washington DC 5/2 that the Center has six active initiatives ongoing as part of its new drugs regulatory program modernization. These include integrated review for marketing applications, IND review management, and post-market safety
Drugs
Hi-Tech Pharmaceuticals says it has sued FDA in DC federal court claiming that the agency “bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.” The complaint states that DMHA has existed in
Drugs
Insys Therapeutics’s founder and four former executives have been convicted by a federal jury in Boston on charges they bribed health professionals to prescribe Subsys, a highly-addictive sublingual fentanyl spray intended for cancer patients experiencing breakthrough pain, and for defrauding Medicare and private insurance carriers. Insys founder John
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Janssen says that an FDA draft guidance on assessing food effects on drugs would be enhanced if the use of physiologically-based pharmacokinetic modeling were permitted and incorporated into the guidance. The company’s comment letter also includes line-by-line specific comments. Specific technical comments also were submitted by
Drugs
Researchers from Harvard Medical School and the Council on Foreign Relations say that recent trade deals containing protections for the drug industry have not always delivered benefits to Americans promised in return for the greater pharmaceutical protections. Writing in the New England Journal of Medicine, the researchers say the 1994
Drugs
FDA has posted a summary of changes made in March and April to 17 risk evaluation and mitigation strategies (REMS). The listings include approval of REMS for four testosterone NDAs, establishment of a shared system REMS for mifepristone, and an additional NDA added to the opioid analgesic shared system.
Drugs
The federal government has intervened in two whistleblower False Claims Act cases alleging that Mallinckrodt’s Questcor Pharmaceuticals unit improperly promoted an expensive multiple sclerosis drug and paid kickbacks to doctors who prescribed the drug, H.P. Acthar Gel. Reuters reports the Justice Department decided to intervene after investigating the
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Sagent Pharmaceuticals has recalled one lot of ketorolac tromethamine injection due to lack of sterility assurance. A recall notice says that microbial growth was detected during a routine simulation of the manufacturing process. The product was manufactured by Zydus (Cadila Healthcare) and distributed by Sagent.
Drugs
An updated Justice Department guidance document reinforces the importance of a robust, well-designed, and effective corporate compliance program in the department’s determination of whether to prosecute, impose monetary penalties, and require compliance obligations on a company accused of misconduct. Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in
Drugs
FDA has approved an Agios Pharmaceuticals supplemental NDA to update the U.S. prescribing information for Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are 75 years
Drugs
Eight public health advocacy organizations are asking FDA acting commissioner Norman Sharpless to continue to reform the monograph system for over-the-counter (OTC) drugs. In a 4/24 letter, the groups (American Academy of Allergy, Asthma, and Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products
Drugs
The House Judiciary Committee has unanimously passed four bills to address prescription drug pricing. A committee media release says that marking up and advancing the four bills is part of the first phase of the committee’s agenda to lower the cost of prescription drugs. The bills are: * H.R.
Drugs
FDA has issued a complete response letter to Heron Therapeutics for its NDA for HTX-011 to manage postoperative pain. The agency told the company it could not approve the NDA in its present form based on the need for additional CMC and non-clinical information. FDA did not identify
Drugs
FDA is struggling to figure out how best to regulate hemp-based cannabidiol (CBD) products after a provision in the 2018 Farm Bill clarified that hemp and hemp products are legal. Shortly after the bill’s passage, former FDA commissioner Scott Gottlieb issued a statement acknowledging that “Congress explicitly preserved
Drugs
FDA has sent Nabriva Therapeutics a complete response letter on its NDA for Contepo (fosfomycin) injection for treating complicated urinary tract infections, including acute pyelonephritis. The letter cited issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers that must be resolved before FDA can