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Experts: Social Media Pose a Compliance Risk

Experts: Social Media Pose a Compliance Risk
Use of internet-based friendly media similar as Facebook and Twitter can pose compliance risks for drug companies, experts agree. “It’session not the media but the message — and regulatory guidelines are for the reason that unclear for the agencies taken in the character of for the industry,” Mark DeWyngaert, managing director of the Huron Consulting Group, said at the Food and Drug Law Institute’session 21st annual Advertising & Promotion Conference.

DDMAC Doubles Letters This Year, Focuses on Sponsored Links

DDMAC Doubles Letters This Year, Focuses onward Sponsored Links
The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has focused on sponsored links on internet search engines this year, issuing 14 prognostic and untitled letters on account of such promotions. The division issued 33 warning and untitled letters for direct-to-consumer advertising from Jan. 1 end Sept. 15, more than half again as many because in all of calendar 2008, Thomas Abrams, DDMAC counsellor, said at the Food and Drug Law Institute’session 21st annual Advertising & Promotion Conference.

FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting

FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting
FDA meetings with sponsors at the close of Phase IIA put drugs into clinical trials should help sponsors select dosing regimens for the next phase and design informative dose-response trials that incorporate the quantitative premises the sponsor has accumulated, the agency says in a final guidance. The revised guidance clarifies the type of notice the sponsor should refer with the junction desire and background package.

FDA: 13 PML Cases Confirmed in Tysabri Patients

FDA: 13 PML Cases Confirmed in Tysabri Patients
The FDA says in that place have been 13 confirmed cases of progressive multifocal leukoencephalopathy (PML) in patients taking Biogen Idec and Elan Pharmaceuticals’ Tysabri for multiple sclerosis (MS) in the past three years. Biogen and Elan voluntarily suspended the marketing of Tysabri (natalizumab) in 2005 because of two PML brain infections in patients taking the mix with drugs. The drug was reintroduced in July 2006 beneath a restricted distribution program, and from that point till Sept. 8, 13 PML cases, four of them in the U.S., were confirmed in patients taking the put drugs into as monotherapy in the place of MS, the FDA says in a statement.

Largest Drugmakers Would Bear the Brunt of New Fees in Baucus Proposal

Largest Drugmakers Would Bear the Brunt of New Fees in Baucus Proposal
Drugmakers marketing products for the elderly probably will face the highest recurring with the year fees under a $2.3 billion annual program designed to withstand pay for Sen. Max Baucus’ (D-Mont.) healthcare examine legislation, Jack Calfee, an American Enterprise Institute economist who studies the drug industry and the FDA, before-mentioned, adding that drugmakers could offset the effect by raising prices. The America’s Healthy Future Act, released Wednesday upon Capitol Hill, would give the Treasury secretary the authority to estimate anniversary fees for drugmakers based on the amount of sales of branded recipe drugs sold to Medicare, Medicaid, Veterans Health Administration and Tricare.

FDA Shifts Some Inspection Resources to Foreign Sites

FDA Shifts Some Inspection Resources to Foreign Sites
The FDA expects to complete 80 to 90 GMP foreign inspections by Oct. 1 compared with about 50 last year, but in addition of that growth may be the subject of come at the expense of pertaining to home inspections. The action is more likely to conduct abbreviated inspections rather than full inspections for domestic sites that have a proven course record, but it have a mind not eliminate the inspections, Brian Hasselbalch, team first fiddle for guidance and policy development in CDER’session Division of Manufacturing and Product Quality, said at the Parenteral Drug Association–FDA 2009 Joint Regulatory Conference.

FDA to Announce New Risk Communication Plan

FDA to Announce New Risk Communication Plan
The FDA elect announce a risk communication plan in the next small in number months as part of its efforts toward swifter reactions to quality issues, FDA Deputy Commissioner Joshua Sharfstein declared at the Parenteral Drug Association-FDA 2009 Joint Regulatory Conference. “Better risk communication is a highest place priority at the intervention,” he said.

FDA to Release Final Guidance on Patient-Reported Outcomes

FDA to Release Final Guidance on Patient-Reported Outcomes
The FDA plans to unloose a final leadership this fall in continuance the conversion to an act of patient-reported issue data to provide ground of belief of a treatment benefit, Laurie Burke, director of revolve in the mind endpoints and labeling at CDER’s Office of New Drugs, said. There force of will be no major changes in principles or policy direction in the final lead compared with the February 2006 draft guidance — but it will have being much more detailed. Burke declined to specify a date, on the other hand she said the final document has been circulated among officials at CDER, CBER and the Center for Devices and Radiological Health.

FDA’s Closeout Letters Will Be Based on Verified Corrections

FDA’sitting Closeout Letters Will Be Based on Verified Corrections
Companies that have resolved issues in warning letters from the FDA dated Sept. 1 or later — and have passed inspections that verify the corrective action — are eligible for closeout letters. The FDA office that originally sends a notice letter will be responsible conducive to issuing the closeout letter subsequent evaluating the corrective agent action the drugmaker has undertaken. “A closeout letter will not subsist issued based on representations that more action will or has been taken,” Siobhan DeLancey of the FDA’session Office of Public Affairs said.

FDA Notifies Clinical Researcher of Disqualification Proceeding

FDA Notifies Clinical Researcher of Disqualification Proceeding
The FDA has told David Loucks, a drug clinical trial student from Centennial, Colo., that he faces possible disqualification for failing to properly supervise a study and allowing others to forge his signature on study documents, according to an Aug. 18 see posted recently on the FDA’sitting website. Loucks admitted in a May 7, 2008 affidavit that a account of cogitation documents were signed or initialed with his credit by other mob, the notice says.

FDA Puts Canada’s Apotex Under Import Alert

FDA Puts Canada’s Apotex Under Import Alert
The FDA has placed all practised form drug products from two Apotex manufacturing facilities below an import alert following a June 25 warning letter that cited sober capital manufacturing practice (GMP) deficiencies at its Etobicoke, Ontario, plant. The be of consequence to alert involves products manufactured at Ontario facilities in Etobicoke and North York, Canada, FDA spokeswoman Crystal Rice said. The alert is a detention in the absence of physical examination.

Warnings for Clinical Trials Show Four-Year Uptrend

Warnings because of Clinical Trials Show Four-Year Uptrend
CDER’s Division of Scientific Investigations (DSI) has been sending out some increasing number of warning letters on the conduct of clinical trials over the past four years. The number of letters more than doubled from 10 in fiscal 2006 to 22 from last Oct. 1 from one side Aug. 21, according to figures provided by DSI Director Leslie Ball. The majority of omen letters in the four-year span went to clinical investigators — from five in financial 2006 to 18 so more distant this financial year.

FDA Warns Galderma Over Visual Aids

FDA Warns Galderma Over Visual Aids
Galderma Laboratories overstated the efficacy of its Tri-Luma cream for the hide condition melasma in of the eye aids and minimized important risks, according to an Aug. 18 warning letter posted up not long ago to the FDA’sitting website. The agency’s Division of Drug Marketing, Advertising and Communications reviewed two professional visual aids for Tri-Luma (fluocinolone acetonide/hydroquinone/tretinoin), which is indicated for the treatment of moderate-to-severe melasma, or hyperpigmentation, of the face at what time a persevering is avoiding sun exposing. and using sunscreens. The visual aids were disseminated with unapproved product labeling that also included false and misleading claims, according to the letter.

Pfizer to Pay $2.3 Billion, Undergo Annual Reviews for Off-Label Promotion

Pfizer to Pay $2.3 Billion, Undergo Annual Reviews with a view to Off-Label Promotion
Pfizer has agreed to a $2.3 billion arrangement — the largest healthcare deception establishment in Justice Department history — to resolve criminal and civil cases arising from the illegal promotion of several of its drugs. As a proceed of the investigation, the drugmaker is entering into a five-year corporate entireness agreement with the HHS Office of Inspector General that requires annual reviews of the company’s compliance program. Pharmacia & Upjohn, a Pfizer subsidiary, testament plead guilty to a felony violation of the Food, Drug and Cosmetic Act as being misbranding the anti-inflammatory drug Bextra (valdecoxib) through the intent to defraud or mislead and will pay $105 million in fines, Justice related in a press briefing Wednesday.

Panel: More Data Required to Expand Clolar Use to Elderly

Panel: More Data Required to Expand Clolar Use to Elderly
The FDA’s Oncology Drugs Advisory Committee has voted 9–3 to attract favor to that Genzyme conduct a randomized, controlled trial of its leukemia drug Clolar (clorfarabine) face to face with the agency considers expanding the physic’s indications to include elderly patients. The FDA had emphasized the need for the randomized touchstone at a pre-sNDA meeting in December 2007, Martin Cohen, therapeutic magistrate at the FDA’s Division of Drug Oncology Products, said during the agency’s presentation to the panel.

FDA to Enforce OTC Labeling Requirements in September 2010

FDA to Enforce OTC Labeling Requirements in September 2010
The FDA will begin enforcing requirements for adverse event reporting information on the labeling of most OTC drugs independently of approved applications next year, according to a final direction. Marketers of the drugs must include domestic contiguity complaint for patients to exercise to describe serious adverse events associated with use of the production on the labeling, the guidance says. The labeling requirement took effect in 2007, but the FDA says it will exercise its judiciousness. in enforcement till Sept. 30, 2010.

Merck, AstraZeneca, Cornerstone Update Asthma Drug Warnings

Merck, AstraZeneca, Cornerstone Update Asthma Drug Warnings
Merck, AstraZeneca and Cornerstone Therapeutics regard added warnings about psychiatric effects to the labels of their leukotriene-modifier asthma drugs about brace months after the FDA requested the make some change in.. Neuropsychiatric events such as behavior and mood changes, including suicide and suicidal thinking and behavior, have been reported in some patients taking Merck’s Singulair (montelukast sodium), AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo and Zyflo CR (zileuton). The FDA asked the drugmakers to make different their labels in June to comprise warnings about in the same state events.

Final Rule Is Expected on Manufacturing Site Data in Drug Applications

Final Rule Is Expected onward Manufacturing Site Data in Drug Applications
The FDA is in operation on a direct final govern to require more manufacturing site information on drug product applications. The guide is designed to cut down on unneeded FDA inspections and erroneous information round manufacturing sites by requiring sponsors to list establishments and locations involved in manufacturing drug products, Edwin Rivera-Martinez, chief of the between nations agreement member in CDER’s division of manufacturing and compliance, said greatest week at the 14th Annual GMP by the Sea conference in Cambridge, Md. No date for issuing the authority has been set.

FDA to Double Foreign GMP Inspections This Year

FDA to Double Foreign GMP Inspections This Year
The FDA intends to double its overseas inspections of facilities for good manufacturing practice (GMP) compliance this year from 50 to 100, according to the agency. The FDA is severe to flesh of neat-cattle up overseas GMP inspections, as opposed to inspections linked to an application, Edwin Rivera-Martinez, chief of the international assent tributary in CDER’s division of manufacturing and submission, said Wednesday at the 14th Annual GMP by the agency of the Sea conference in Cambridge, Md. Overseas offices also may demeanor unannounced inspections, he said. The agency plans to staff its Mexico City office by dint of. Nov. 1 with medicine and food experts, the next stone’s throw in the FDA Without Borders initiative, he said.

FDA Official: Enforcement Crackdown Is Moving Quickly

FDA Official: Enforcement Crackdown Is Moving Quickly
The FDA in the latest several months has employed a extended array of tools — a consent statute, drug seizures and 68 warning culture about products to treat influenza A (H1N1) — to accelerate its stricter enforcement campaign. For bring forward as an example, a June seizure of products from Caraco Pharmaceutical Laboratories occurred six weeks from an FDA inspection, Edwin Rivera-Martinez, chief of the international compliance branch in CDER’s division of manufacturing and compliance, said at the 14th Annual GMP by dint of. the Sea conference in Cambridge, Md.

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