Drugs
A 6/2017 conference convened by the Yale Collaboration for Research Integrity and Transparency that brought together concerned academics, patient advocates, legal and medical experts, and leaders from international organizations to talk about serious problems and dysfunctions in how medicines are developed, tested, reviewed, marketed and used, developed seven points
Drugs
FDA has placed a clinical hold on Bellicum Pharmaceuticals’ U.S. studies of its BPX-501 after reports of three cases of encephalopathy possibly related to the drug. The company says it is awaiting formal FDA communication on the requirements for resuming studies, and will work closely with the agency
FDA Policy/General
A recent Justice Department directive requires that civil litigators who bring affirmative civil enforcement (ACE) cases not convert other agency guidance documents into binding rules. Attorneys Anne Walsh and Rachel Hunt (Hyman. Phelps & McNamara) write in their firm’s FDA Law Blog that associate attorney general Rachel Brand said
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Merck’s Keytruda (pembrolizumab) to be 1,338 days. Of this time, 1,148 days occurred during the testing phase and 190 days occurred during the approval phase. Keytruda is a programmed death receptor-1
FDA Policy/General
Federal Register notice: FDA has announced a 4/16 public meeting on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to improve enrollment
Drugs
President Donald Trump acknowledged FDA and its record approvals last year in his 1/30 State of the Union address. “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history,” he
Drugs
Alkermes has filed an NDA for ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder (MDD). The submission is based on data from more than 30 clinical trials and more than 1,500 patients with MDD. Buprenorphine is a partial
Devices
The Justice Department (DoJ) says the South Dakota federal court accepted 1/31 a guilty plea entered by Robert Lytle to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt. The pleas came in
Devices
FDA says that Physicians Products Inc. is selling its Sterile PRP Separation Kit online in violation of the Federal Food, Drug, and Cosmetic Act since it does not have a PMA approval or IDE in effect. “On your Web site, you market the product as ‘FDA approved,’ and offer it
Drugs
FDA has granted Aquestive Therapeutics an orphan drug designation for riluzole oral soluble film (OSF) for treating amyotrophic lateral sclerosis (ALS), which affects about 30,000 Americans. Riluzole OSF is currently in late-stage clinical development. Patients suffering from ALS often have difficulty swallowing. Riluzole film was developed to dissolve
Drugs
FDA has approved a Ferring Pharmaceuticals supplemental NDA for Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH), indicated for hormone replacement in adults with GH deficiency. The drug was previously approved for treating pediatric patients who have growth failure due to an inadequate secretion
Drugs
A Massachusetts federal judge sentenced Aegerion Pharmaceuticals for improperly marketing its Juxtapid cholesterol drug and ordered that some of the $40.1 million it agreed to pay as part of a plea bargain be divided among some of the company’s victims. A Reuters report says that prosecutors had charged
Devices
Masimo has received 510(k) clearance to sell its next-generation SedLine brain function monitoring device for use in anesthetized and sedated patients. The device acquires and processes electroencephalogram (EEG) signals, providing physicians brain function data on anesthetized patients. The revised SedLine “benefits from work to improve the patient state
Devices
A 10/21-11/17/17 FDA inspection at Light Age, Inc., Somerset, NJ, found 12 Quality System Regulation violations in the firm’s manufacturing of Class 2 medical lasers, including EpiCare and Q-Clear. A 1/24 Warning Letter says specific violations listed on an FDA-483 were: * failing
Drugs
A 7/18-7/21/17 FDA inspection at Daito Kasei Kogyo, Okayama, Japan, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 1/18 Warning Letter. Specific deviations were: * failing to ensure that appropriate laboratory tests are conducted for each batch
Drugs
A 7/24-7/28/18 FDA inspection at Hunan Norchem Pharmaceutical Co., Hunan, China, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API) , according to a 1/9 Warning Letter. Specific deviations were: * · failing to prepare and use production and control records for each
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Qualified Infectious Disease Product Designation Questions and Answers.” The document discusses available incentives for developing antibacterial and antifungal drug products that treat serious or life-threatening infections. It is also intended to serve as an information resource on FDA’
FDA Policy/General
Federal Register notice: FDA has classified the surgical smoke precipitator into Class 2 (special controls). The action is in response to a de novo classification request by Alesi Surgical for the Ultravision Visual Field Clearing System. It is a prescription device intended for clearing the visual field by precipitation of
Drugs
FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium). In a revised drug safety alert, the agency says most events are among people who are intentionally misusing or abusing
Devices
FDA has issued two final guidances explaining the procedures and criteria the agency intends to use in accepting or refusing a 510(k) or PMA submission. The guidances include checklists to identify the necessary elements and contents of a complete application. FDA says the updates in the documents address provisions
Drugs
FDA has revised its document entitled “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which contains core educational messages for those involved. It also includes more information on pain management, including principles of acute and chronic pain management; non-
Drugs
FDA has released the FDA-483 issued following a 1/16-1/19 inspection at Shilpa Medicare Limited, Raichur, Karnataka, India. Observations in the form were: * equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality, or purity of the intermediates