Drugs
A 9/29-10/20/16 FDA inspection at Raritan Pharmaceuticals, East Brunswick, NJ, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 6/20 Warning Letter from the agency’s New Jersey District Office. Specific violations cited in the letter are: * failing to
Drugs
A Journal of Law, Economics & Policy article on how off-label promotion may help patients is being praised by attorney Stephen McConnell (Reed Smith) in a Drug & Device Law blog post. McConnell says the article is “a sane, clear-eyed appraisal of why off-label use of drugs
FDA Policy/General
An 11/7-11/10/16 FDA inspection at Pulmonary and Sleep Center of the Valley, McAllen, TX, conducted as part of the Bioresearch Monitoring Program, determined that the center did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection
Drugs
The Securities and Exchange Commission has filed insider trading charges against two former employees and the spouse of a former employee of Ariad Pharmaceuticals for allegedly trading in advance of FDA decisions that impacted the sales and marketing of the company’s main cancer drug. According to the SEC’s
Drugs
FDA says that to minimize the possibility of further legal challenge, it has determined that in accordance with the DC federal court holding in Ferring Pharmaceuticals v. Burwell, Gilead’s Stribild (cobicistat; elvitegravir; tenofovir disoproxil fumarate) is eligible for five-year new chemical entity (NCE) exclusivity because it contains cobicistat
Drugs
Hogan Lovells attorneys say that the FDA 6/21 draft guidance on using electronic records and electronic signatures in clinical investigations is “a significant development because it signals that FDA nay be preparing to place greater scrutiny on electronic systems used in clinical trials to ensure that those systems meet
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Adolfo E. Kaplan, Pulmonary and Sleep Center of the Valley McAllen, Texas (4/20) FDA inspected the clinical investigator’s site 11/2016 and it observed objectionable conditions associated
Drugs
FDA says that PharMEDium Services has issued a nationwide recall of specific lots of potassium phosphate and succinylcholine chloride due to a lack of sterility assurance. An agency publication of a company announcement says that PharMEDium Services’ recall is due to Hospira’s 6/15 recall announcement that microbial growth
Drugs
Fera Pharmaceuticals is asking FDA not to approve any ANDA for levothyroxine injection 100 mcg/vial and 500 mcg/vial until the company’s 180-day exclusivity has expired. In its petition Fera says the agency should not approve any ANDA, including InnoPharma’s, because Fera is the sole “first
Drugs
Barely a week after he called for public input on the problem, a group of senators have urged FDA commissioner Scott Gottlieb to address prescription drug costs by curbing abuses by drug companies to delay competition. Senator Dianne Feinstein (D-CA) joined a bipartisan group of Senate Judiciary Committee members
Drugs
GMP issues cited during a 2016 inspection at Pfizer’s McPherson, KS manufacturing facility (Hospira) have led to a a complete response letter on a BLA for a proposed biosimilar referencing Amgen’s Epogen/Procrit (epoetin alfa). A Warning Letter was issued 2/14 (see earlier story) after FDA conducted
Drugs
FDA commissioner Scott Gottlieb says he would like to make redacted complete response letters publicly available. Patient groups and certain other stakeholders have been asking the agency for years for more information when the agency rejects an NDA or BLA. And now-retired CDER Office of New Drugs director John
Drugs
FDA’s Generic Drug User Fee Amendments of 2012 (GDUFA) program had a $174 million carryover in fiscal year 2016, but it lacked a plan for administering this carryover — “one that includes a fully-documented analysis of program costs and risks to ensure that program operations can be sustained in
Drugs
“Big Pharma has captured the Trump administration.” That is the bottom line in a Public Citizen analysis of a draft executive order on prescription drug pricing and innovation that president Trump is expected to soon sign. The analysis echoes concern from experts who talked to the New York Times earlier
Drugs
An Indiana compounding pharmacy owner and compliance director have been charged criminally in connection with their distribution of over- and under-potent drugs, and defrauding the U.S. by interfering with and obstructing FDA’s lawful duties, according to the Department of Justice (DoJ). Pharmakon Pharmaceuticals’ Paul J. Elmer (Fishers,
Drugs
FDA has approved a Portola Pharma NDA for Bevyxxa (betrixaban) for preventing venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. An FDA notice says the most
Drugs
The U.S. Chamber of Commerce says that a survey sponsored by its Institute for Legal Reform shows that 25% of Americans taking certain prescribed medicines say they would stop taking the drugs immediately without consulting their doctor after seeing ads promoting lawsuits against the drugs’ manufacturers. The Chamber says
Drugs
FDA says it has established a public docket to invite discussion of issues related to adoption of continuous manufacturing by the drug industry. A Federal Register notice to be published 6/23 says that the agency agreed during a 5/7/15 workshop on the future of pharmaceutical manufacturing that
Drugs
FDA has granted Zogenix an orphan drug designation for its investigational drug, ZX008 (low-dose fenfluramine), for treating Lennox Gastaut Syndrome (LGS), a refractory, debilitating childhood-onset epilepsy. An IND was approved in April for a Phase 3 LGS study involving the drug. Zogenix is currently conducting a Phase 3
Drugs
[This report has been updated to remove incorrect attribution.] Starting early next year, FDA will begin encouraging a voluntary quality metrics reporting program to calculate three metrics, CDER Office of Surveillance acting director Sarah Pope Miksinski told a Drug Information Association (DIA) session in Chicago 6/21. Late last year,
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) establishing policies and procedures for review staff in the Office of New Drugs for the review and management of financial disclosure information submitted in NDAs and BLAs and supplements to them. A 1998 final rule “is intended to ensure that
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing Office of Generic Drugs policies and procedures for reviewing bioequivalence studies with clinical endpoints submitted in ANDAs. The document says before 2000, all comparative clinical endpoint studies submitted in ANDAs were referred to the appropriate Office of New Drugs